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Sylentis Initiates a Phase III Study for the Treatment of Dry Eye Syndrome

Posted by australiandryeye on June 9, 2017 at 4:05 AM Comments comments (0)

The pharmaceutical Company Sylentis (PharmaMar Group) has announced the start of the first Phase III study, HELIX, with the investigational new drug, SYL1001 for the indication of dry eye syndrome. The Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program, which is designed to support the submission of a New Drug Application (NDA). The Company has received final, End-of-Phase II meeting minutes from the FDA.


(Logo: http://photos.prnewswire.com/prnh/20150203/727958-b )

SYL1001 is an advance in the development of innovative compounds in different therapeutic fields, through the novel technology of gene silencing, based on RNA interference (RNAi). In the HELIX study, more than 30 centers from 5 European countries (Spain, Germany, Estonia, Portugal and Italy) will participate with the objective of evaluating the effect of the ophthalmological solution SYL1001 for improvements in the signs and symptoms of dry eye syndrome in about 300 patients an area in which few therapeutic options exist today. SYL1001 is a compound based on RNAi being administered in the form of eye drops that block the synthesis of a receptor implicated in the pathology of dry eye syndrome.

 

Pharma Mar SA


Patients with dry-eye syndrome suffer the chronic loss of lubrication and hydration on the ocular surface. The risk of developing this disorder increases in 35% every decade thereafter[2]. Around the world, 344 million people suffer from this syndrome.


 

Dry eye syndrome is characteristic in people that live in developed countries and is caused by pollution, air conditioning, the use of contact lenses, refractive eye surgery or the continued use of computers. The most common symptoms of this pathology are burning, a constant itching, eye fatigue, dryness, blurred vision, the sensation of having a foreign body or eye pain[1], are some of the symptoms


 

As explained by Dr Ana Isabel Jimenez, COO and Director of R&D at Sylentis, "the RNA interference on which we are working, could improve the signs and symptoms for patients that suffer from this syndrome, given that this compound could reduce the inflammatory parameters of the eye´s surface, could improve the quality of the tear and could reduce the ocular pain associated with dry eye syndrome. We consider that our molecule SYL1001 could be a very effective and important therapeutic alternative for these patients".


 

The Company is working on the investigation of new treatments for ophthalmological and inflammatory illnesses. "Up to today, the line of work in which we have more rapidly advanced in is in ophthalmology, for the treatment of illnesses such as dry eye syndrome, glaucoma, ocular allergies and illnesses of the retina", added Dr Jimenez.


 

What is RNA interference?


 

RNA interference is an innovative technology that looks for a reduction in the anomalous production of protein, silencing the RNA Messenger. The RNAi provides a step forward, as it provides a new mechanism of action to confront numerous pathologies[2]. Nowadays there are two marketed products based on this technology and there are several drugs in different phases of clinical development.


 

Pathologies, such as dry eye syndrome, are produced by an alteration in certain proteins. Through this technology, the production of proteins that take part in various pathologies could be decreased or very specifically controlled[3].


 

HELIX, a clinical trial study



With the purpose of progressing in this field, Sylentis has begun the multicenter, random, controlled and double blind Phase III clinical trial in more than 30 hospitals in Spain, Germany, Estonia, Portugal and Italy. The trial, in which 300 patients are going to be enrolled will evaluate the efficacy of the product patented by Sylentis, SYL1001, in the treatment of the signs and symptoms of dry eye disease[4].


 

For more information about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT03108664?term=SYL1001&rank=2


 

For more information (only available in Spanish)



Whats is RNA interference? https://youtu.be/T21N_dPM0_k



Dry eye syndrome: https://youtu.be/R-h_4_Yyq2g


1. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf, 2007. 5(2): p. 75-92


2. Martínez T, Jimenez AI, Pañeda C. Short-interference RNAs: becoming medicines. EXCLI Journal, 2015;14:714-46

 

3. Pañeda C, González V, Martínez T, Ruz V, Vargas B and Jimenez AI. RNAi based therapies for ocular conditions. In Proceedings of the 11th ISOPT,2014, 25-30, Medimond, Bologna, Italy

 

4. Benitez-Del Castillo JM [https://www.ncbi.nlm.nih.gov/pubmed/?term=Benitez-Del-Castillo%20JM%5BAuthor%5D&cauthor=true&cauthor_uid=27893109 ], . Protocol No.: SYL1001_IV. EUDRACT No: 2016-003903-79. A double-masked study of SYL1001 in patients with moderate to severe dry eye disease (DED). HELIX Study (Phase III). Version 1.1: December 14th, 2016. Sylentis SAU-Pharma Mar Group


 

CONTACTS : Media Relations (+34-638-79-62-15) and Investor Relations (+34-914444500)

 

SOURCE PharmaMar

Aldeyra Therapeutics Announces First Patient Enrolled in Dry Eye Disease Phase 2a Clinical Trial

Posted by australiandryeye on June 9, 2017 at 4:00 AM Comments comments (0)

LEXINGTON, Mass., June 6, 2017 /PRNewswire/ -- Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage biotechnology company devoted to treating inflammation, inborn errors of metabolism, and other diseases related to aldehydes, today announced that it has enrolled the first patient into a Phase 2a clinical trial of topical ocular ADX-102 for the treatment of Dry Eye Disease (DED).


 

"Dry Eye Disease is a common ocular inflammatory condition with high unmet medical need, representing one of the largest ophthalmic markets worldwide," commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Based on the success of ADX-102 in two ocular inflammation Phase 2 clinical trials announced last year, we are pleased to initiate clinical development in this disease, and we expect to report results in the third quarter of this year."



ADX-102 and other product candidates generated from Aldeyra's aldehyde trap platform sequester and facilitate the degradation of aldehydes, a class of endogenously generated pro-inflammatory mediators that are elevated in DED patients. The Phase 2a clinical trial will test three formulations of topical ocular ADX-102 over 28 days of dosing. Endpoints will include standard signs and symptoms characteristic of DED.


 

A clinical trial synopsis is available on clinicaltrials.gov (NCT03162783).


 

About Aldeyra Therapeutics

Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules. Aldeyra's lead product candidate, ADX-102, is an aldehyde trap in development for ocular inflammation, as well as for Sjögren-Larsson Syndrome and Succinic Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of aldehyde metabolism. Aldeyra's product candidates have not been approved for sale in the U.S. or elsewhere.



About Dry Eye Disease

Dry Eye Disease is a common inflammatory disease characterized by insufficient moisture and lubrication in the anterior surface of the eye. Symptoms may include ocular irritation, burning or stinging, and, in severe cases, decreased vision. In patients with Dry Eye Disease, aldehydes may contribute to ocular inflammation as well as the impairment of lipids (fats) that lubricate the surface of the eye.


http://www.prnewswire.com/news-releases/aldeyra-therapeutics-announces-first-patient-enrolled-in-dry-eye-disease-phase-2a-clinical-trial-300469154.html

Lamellar Biomedical Recruits First Patients Into Clinical Study Assessing LAMELLEYE for Treatment of Dry Eye Disease

Posted by australiandryeye on June 9, 2017 at 4:00 AM Comments comments (0)


Lamellar Biomedical, a biotechnology company developing a range of patent-protected medical and pharmaceutical products, based on its LAMELLASOME™ technology, announces the recruitment of the first patients in a clinical study assessing LAMELLEYE for the treatment of moderate to severe Dry Eye Disease (DED). Moderate to severe DED is a significant clinical problem for which there are no effective treatments that tackle the underlying cause.



LAMELLEYE is designed to provide unique lubricating properties to patients with DED based on LAMELLASOME[TM] technology's ability to mimic the actions of serous lamellar bodies. The new study will assess the clinical utility of LAMELLEYE and compare its performance with Optive Plus, a leading over-the-counter eye-drop for patients with DED.


 

The single-blind, randomised, cross-over study will recruit 30 patients and the results are expected to be reported in the second half of 2017. The study aims to collect clinical follow-up data on the use of LAMELLEYE and to assess the relative effectiveness of LAMELLEYE compared with the Optive Plus comparator eye drop. Outcomes include: non-invasive tear breakup time, symptom scores, rate of tear film evaporation (evaporimetry) and effect on the structure and quality of the tear film (interferometry).



LAMELLEYE is a medical device, which received an EU CE mark in 2015. 


Dr. Alec McLean, CEO of Lamellar Biomedical said, "We believe that LAMELLEYE has the potential to be an important advance in the treatment of DED given the unique lubricating properties of our LAMELLASOME[TM] technology. We anticipate that this new study will provide conclusive evidence of the clinical benefits that LAMELLEYE can deliver and demonstrate its superiority over an existing product for the relief of dry eye disease. We are looking forward to announcing the results of the study later this year, as they will be used to support the commercialization of this exciting new treatment in Europe in 2018, through a partner."



Lamellar Biomedical has recently concluded a £5.75 million fundraising, which was led by Invesco and supported by the Scottish Investment Bank.

 


About Dry Eye Disease (DED)

 


The major cause of Dry Eye Disease (DED) is when the outer lipid layer is deficient, allowing the eye to dry due to increased evaporation.

 

The consequences of DED are multiple, including symptoms of discomfort, burning and of grit in the eye. Visual disturbance is common with potential for damage to the cornea including long-term scarring and subsequent loss of vision. In severe cases Filamentary Keratitis can develop. This is a painful lesion where mucus filaments stick to the corneal surface and with each blink, the eyelids tug at the filaments, stimulating pain-sensitive corneal nerves. 


The market for dry eye products is large and growing encompassing prescription and OTC products which in aggregate generate sales in excess of US$2 billion per annum and which are anticipated to grow significantly.


About Lamellar Biomedical


Lamellar Biomedical is the only company globally focused on LAMELLASOME[TM] technology (micron-scale lipid vesicles), which has multiple medical applications.


Lamellar Biomedical's development pipeline includes a number of patent-protected medical devices and pharmaceuticals targeting Dry Eye Disease, Dry Mouth in Head and Neck cancer, Cystic Fibrosis and Infection. These are all conditions that are poorly served by current medications and therefore represent areas of high value unmet medical need.



LAMELLASOME[TM] technology produces mimetics of human serous lamellar bodies. These regulate the internal interfaces between human tissues as well as the interfaces between tissues and the external environment as in the mouth and lungs. They act biophysically, are muco-restorative and have the potential to resolve a broad range of disease states that are associated with dry or sticky mucosal surfaces and topical infection. 


Lamellar Biomedical is based near Glasgow, Scotland. It has been financed by a range of investors including Invesco, Scottish Enterprise, Barwell and TRI Capital. In March, the Company raised £5.75 million in a Series C fund raising.


For more information please visit: http://www.lamellar.com


For further information, please contact:


Lamellar Biomedical

Dr. Alec McLean

[email protected]

Tel: +44-(0)-1698-748832

Citigate Dewe Rogerson

David Dible / Shabnam Bashir

[email protected]

Tel: +44-(0)-20-7282-1022

SOURCE Lamellar Biomedical

http://www.prnewswire.com/news-releases/lamellar-biomedical-recruits-first-patients-into-clinical-study-assessing-lamelleye-for-treatment-of-dry-eye-disease-625457474.html

RegeneRx JV Presents Results of Phase 2b/3 (ARISE-1) Dry Eye Trial at ARVO 2017

Posted by australiandryeye on May 14, 2017 at 6:50 AM Comments comments (0)

ROCKVILLE, Md., May 9, 2017 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced that its joint venture, ReGenTree LLC, presented the results of its ARISE-1 Phase 2b/3 dry eye clinical trial in a poster session to physicians, scientists, and analysts today at the 2017 ARVO meeting in Baltimore, Maryland.


As previously reported, the double-masked, placebo-controlled trial in 317 patients with dry eye syndrome demonstrated that after 28 days of treatment, RGN-259 was safe and significantly reduced ocular discomfort both during and after exposure to a controlled adverse environment (CAE®;). Ocular discomfort is a symptom of dry eye syndrome. ReGenTree also reported that after 28 days of treatment RGN-259 significantly reduced total and inferior corneal fluorescein staining in a subgroup of subjects with compromised baseline tear film break-up time, which is a sign of dry eye syndrome. Both symptom and sign improvements are typically required by FDA to obtain marketing approval of a pharmaceutical treatment for dry eye.


A second Phase 3 dry eye trial (ARISE-2) designed to reproduce the results seen in ARISE-1 is currently underway in the U.S. with over 500 patients. The trial is expected to be completed by the fall of 2017.

 

About RGN-259 for the Treatment of Dry Eye Syndrome

 

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (Tβ4). Based on U.S. Phase 2 and Phase 2b/3 clinical trials in moderate and severe dry eye syndrome, RGN-259 is safe and found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. The data from these trials, as well as a previously completed clinical trial of RGN-259 in patients with NK, reflect RGN-259's mechanisms of action, support the "protective" effects of RGN-259, and provide FDA-approvable clinical endpoints to be targeted in these and any future clinical trials. Dry eye syndrome is a multifactorial disease and it is well known that Tβ4 can elicit a spectrum of therapeutic responses, including promotion of cell migration and proliferation, reduction of inflammation and acceleration of corneal epithelial growth and would represent a major step forward from current treatment options.

 

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

 

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world. RGN-259, the Company's Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome. The dry eye trial results were announced in May 2016 and ReGenTree subsequently received permission from the U.S. FDA and has initiated a second Phase 3 trial in approximately 500 patients that is expected to be completed in the fourth quarter of 2017. ReGenTree is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-352, the Company's Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke. For additional information about RegeneRx please visit www.regenerx.com.

 

About ReGenTree LLC

 

ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in the U.S. and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. While G-treeBNT is the majority owner of ReGenTree, RegeneRx retains a significant minority interest in the joint venture, in addition to a royalty on commercial sales, and is represented on the board of ReGenTree. Certain commercial and financial transactions require RegeneRx approval. G-treeBNT is responsible for operations of the venture and all funding required for clinical development of RGN-259 in the U.S. For additional information about ReGenTree, please visit www.regentreellc.com.

 

Forward-Looking Statements

 

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Forward-looking statements used in this press release relate to, among other things, the quality of clinical data, the activity of the active ingredient in our product candidates, and the expected timing of initiation and completion clinical trials in the United States and the potential benefits to RegeneRx of such trials. There can be no assurance that any proposed clinical trial will start within the estimated initiation timeframe or be completed within the estimated timeframe or that positive results from any clinical trials or research by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2016, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

 

SOURCE RegeneRx Biopharmaceuticals, Inc.

 

Related Links

 

http://www.regenerx.com


http://www.prnewswire.com/news-releases/regenerx-jv-presents-results-of-phase-2b3-arise-1-dry-eye-trial-at-arvo-2017-300454170.html

Shire pays $20M for Parions midstage dry eye drug

Posted by australiandryeye on May 13, 2017 at 3:35 AM Comments comments (0)

Shire will pay $20 million upfront, with a potential $535 million biobucks if all goes according to plan, for Parion Sciences’ dry eye candidate P-321 as it looks to boost its ophthalmology pipeline.


The deal sees Shire gain exclusive worldwide rights to develop and commercialize P-321, where it will also lead development. The biopharma added that Parion will have “an opportunity to co-fund” work on the medication.

 

P-321 works as an epithelial sodium channel (ENaC) inhibitor and is in phase 2, targeting tear volume deficiency and promoting ocular surface healing. ENaC is believed to block the absorption of tears, and help keep the ocular surface hydrated; current meds target the effects of ocular inflammation, so Parion thinks it has a different med on its hands than those on the market.

 

“Ophthalmics is a continued focus for Shire, and the program for P-321 will benefit from our development and commercial infrastructure and expertise,” said Shire CEO Flemming Ornskov, M.D., M.P.H.

 

“This is an opportunity to apply our knowledge and experience from ophthalmics and dry eye disease for further innovation in this space. If approved, P-321 would expand our eye care portfolio.”

 

“Advancing P-321 with Shire, an emerging global leader in ophthalmics, offers the expertise and resources to move this promising potential therapy for dry eye sufferers forward," added Paul Boucher, president and chief executive of Parion.

 

“This collaborative license agreement enables us the opportunity to contribute and participate in P-321’s success, while continuing our drive to progress Parion’s pipeline of novel therapies.”

 

Full financial details were not on show, but Shire will stump up $20 million in the form of a license payment, with an additional $20 million payment in the works if things go well in the shorter term. Longer term, Parion could see the deal worth up to $535 million in biobucks if it ticks all of the milestone boxes.

 

The biotech also has the option to co-fund through additional stages of development in exchange for boosted royalties. It can also choose to co-fund any sales push and “participate in the financial outcome from those activities,” according to the pact.


http://www.fiercebiotech.com/biotech/shire-pays-20m-for-midstage-for-parion-s-dry-eye-drug

New View of Dry Eye Stresses Mechanisms Over Manifestations

Posted by australiandryeye on May 13, 2017 at 3:35 AM Comments comments (0)

The Tear Film & Ocular Surface Society (TFOS) presented the conclusions and recommendations of the TFOS Dry Eye Workshop II (DEWS II) during a special session of the Association for Research in Vision and Ophthalmology (ARVO) 2017 Annual Meeting in Baltimore, Maryland, yesterday.

TFOS is a nonprofit, global organization that aims to improve understanding of the composition and regulation of the preocular tear film and its function in maintaining the cornea and conjunctiva, preventing infection, and preserving visual acuity. The group is a collaboration among scientists, clinicians, and industry professionals.

Definition Updated


The first dry eye workshop, held in 2007, "launched an increase in basic and clinical research to better understand dry eye, which affects 40 million people in the [United States], 10 million severely," David A. Sullivan, PhD, senior scientist at the Schepens Eye Research Institute/Massachusetts Eye and Ear and associate professor at Harvard Medical School, Boston, told Medscape Medical News.

The DEWS II report, which will be published in late June in Ocular Surface Journal, presents "a global consensus of the epidemiology, mechanisms, diagnosis, management, impact, and classification" of the condition, Dr Sullivan said. "We're distributing the report to hundreds of thousands of eye care practitioners in many languages," he added.

Among the key points in the new report is an updated definition of dry eye that is more mechanistic. Whereas the 2007 definition emphasized the symptoms of the disease, the 2017 definition describes the underlying causes of the disease: "Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles," Jennifer P. Craig, PhD, MCOptom, the workshop vice-chair, said in a TFOS news release.

A Shifting View

Fifteen to 20 years ago, dry eyes were attributed, logically, to insufficient water. Since then, "we've learned a tremendous amount. Now we know that androgens affect the lid and the main lacrimal glands, and regulate the Meibomian glands," Dr Sullivan said.


In Sjogren's syndrome and complete androgen insensitivity syndrome, the Meibomian glands do not make enough oil to prevent evaporation of tears, triggering a cascade of events that ultimately damages the ocular surface. "The tears do not start to concentrate, and receptors on the cornea trigger sensations of pain and discomfort. This decreases the ability of the eye surface to hold water and increases the instability of epithelial cells, which may die," Dr Sullivan continued. Meanwhile, cytokines pour out and trigger inflammation.

The new description of the disease grew out of the realization that markers of dry eye reflect "a significant role for osmolarity and inflammation," said chair of the session J. Daniel Nelson, MD, associate medical director for specialty care for HealthPartners Medical Group and Clinics in St Paul, Minnesota. Since the first report, the technical literature related to dry eye has almost doubled, he added.

"Classically, we'd say that dry eye is aqueous or evaporative. We know now that most people have a combination," Dr Nelson said.

The new definition also recognizes a role for the neurophysiology in the sensory aspect of the disease, which emerged from the disconnect between signs and symptoms in some patients. An individual with signs, but not symptoms, may have a pre-dry eye situation, Dr Nelson suggested. The reverse — patients with symptoms but no signs — may actually have neuropathic pain and not dry eye.

Underlying Causes


The new report also delves into causes of dry eye, which include autoimmune diseases, eye surgery that damages the ocular surface, use of certain types of drugs (diuretics, beta-blockers, and topical medications for glaucoma), blepharitis, eyelids that turn in or out, overuse of contact lenses, and prolonged staring at a lit screen, which reduces blinking.

At the DEWS II session, researchers also discussed the design of clinical trials to assess new drugs. "Dry eye doesn't have a cure, and there isn't a treatment for Meibomian gland dysfunction, which is the major cause," Dr Sullivan said, adding that drugs approved by the US Food and Drug Administration are anti-inflammatories. "They deal with the situation downstream, but not the underlying problem."

Meanwhile, Dr Nelson shared with Medscape Medical News that he helps patients take "a Sherlock Holmes approach" to identifying actionable environmental triggers such as seasonal allergies, exposure to irritants at work, and cosmetics, creams, and cats. "A woman may go to bed with facial cream on, but anything touching the lower lid gets into the tear ducts very quickly," he said. Cat saliva on human bedding deposits allergens that can trigger dry eye even after the cat has relocated.

Some patients simply learn to live with dry eyes, perhaps by minimizing environmental triggers, Dr Nelson noted.

Paradoxically, dry eye is the leading cause of visits to eye care practitioners, yet one study estimates that slightly more than half of affected individuals have not sought professional care, Dr Sullivan said. He adds that "the prevalence has not been fully appreciated."

More than 150 clinicians and researchers worked on the 2017 report. "It's great bringing people from all over the world together to move our understanding forward and have increased research translate into new strategies to improve the quality of life for people with this common disease," Dr Sullivan added.

Numerous companies fund TFOS, including Alcon, Novartis, Shire, Allergan, Bausch + Lomb, Akorn, CooperVision, Dompé, Horus Pharma, Lubris BioPharma, Oculeve, Sun Pharma, TearLab, SIFI, Johnson & Johnson Vision Care, Carl Zeiss Meditec/ZEISS Group, Quint Health, Scope Ophthalmics, and Senju. The authors have disclosed no other relevant financial relationships.

TFOS DEWS II Report. May 7, 2017.


http://www.medscape.com/viewarticle/879675

Sylentis announces new preclinical and clinical data for its SYL1001 molecule during ARVO 2017

Posted by australiandryeye on May 10, 2017 at 1:30 AM Comments comments (0)

SYL1001 is a compound under investigation for the treatment of dry eye disease.


It is a product based on the novel technology RNA interference (RNAi), developed for the treatment of signs and symptoms of this illness.

 

At the Annual Congress of the Association for Research in Vision and Ophthalmology 2017, around 11,000 attendees will meet form the 7-11 of May in Baltimore, USA.

 

Madrid, May, 9th, 2017. In the framework of the Annual Congress of the Association for Research in Vision and Ophthalmology 2017 (ARVO), being held from the 7-11 of May in Baltimore (USA), Sylentis, a pharmaceutical company from the PharmaMar Group (MSE:PHM), presents new preclinical and clinical developments with its molecule SYL1001 for the treatment of dry eye disease. This is a product based on the novel technology RNA interference (RNAi), developed for the treatment of the signs and symptoms of this pathology.

 

This Congress will bring together more than 11,000 top eye and vision researchers and clinicians from around the world to explore cutting-edge basic and clinical science. “We are proud to be able to present our results to such a well prepared audience. We trust our technology, innovative in its field, and we hope that SYL1001 will soon be a real alternative for treating millions of people that suffer from dry eye disease around the world”, states Ana Isabel Jiménez, R&D Director of Sylentis.

 

Accordingly, Sylentis participates at this event with the presentation of data from various clinical and preclinical trials. On one hand, the stability results of SYL1001 in different commercial containers. The stability of the compound in various containers and conditions through time concludes that all the formats analyzed guarantee the integrity and specifications of the product.

 

On the other hand, Sylentis has presented the results of the study of this product in animal models, to evaluate its efficacy in the treatment of the symptoms and signs of dry eye disease. These patients have a deficit of mucine, a protein found in tears, a low density in the goblet cells and inflammation of the ocular surface. These studies have concluded that SYL1001, apart from reducing the feeling of ocular discomfort, it also improves the quality of the tear and reduces inflammation. In animal models, the statistical increase in the levels of mucine (MUC5A+) present on the eye´s surface has also been demonstrated, allowing for the formation of a tear film. In this same study, an increase in the density of goblet cell (those producing and secreting mucine) and also in tear secretion was observed. The inflammatory mediators of the eye surface also decreased after treatment.

 

Finally, the Company presents a third study that demonstrates the existing correlation between the preclinical and clinical results in the search for the optimum and most efficient dose. Both, in animal and human models, the concentration of 1.125% of SYL1001 was observed to be the most efficient, along with a very low incidence of adverse events.

 

Principle studies of Sylentis to be presented at ARVO 2017:

 

Stability study of SYL1001 eye drops (a siRNA compound) for DED in different containers (Posterboard Number: 476 – A0401)

Session: 7th of May of 2017, from 13:30 to 15:15 hours. Lead author: Verónica Ruz, et al. Regulatory Affairs, Sylentis, Spain.

 

Efficacy of SYL1001 in different animal models of Dry Eye Disease (Posterboard number: 458 – A0383)

Session: 7th of May of 2017, from 13:30 to 15:15 hours. Lead author: Ana Isabel Jiménez et al. R&D, Sylentis, Spain.

 

Clinical and preclinical study correlation for SYL1001, a new treatment for dry eye disease (Posterboard number: 2670 – A0260)

Session: 9th of May of 2017, from 8:30 to 10:15 hours. Lead author: María Victoria González et al. Clinical Department, Sylentis, Spain.

 

About SYL1001

SYL1001 is a drug based on RNAi that is administered as preservative-free eye drops; it selectively inhibits production of the TRPV1 receptor. These receptors are ion channels that mediate the transmission of ocular pain. SYL1001 is a small synthetic double-stranded RNA oligonucleotide (siRNA) with a novel and highly selective mechanism of action. Non-clinical studies conducted by Sylentis with SYL1001 have demonstrated it has high ability to inhibit this specific target and block the perception of ocular pain in animals .

SYL1001 is a product undergoing development for the treatment or prevention of ocular pain related to with dry eye syndrome, and has potential to be developed for other pathologies that cause ocular pain (corneal lesions, refractive surgery, etc.).

 

About RNA interference (RNAi)

RNA interference (RNAi) is a natural cellular process that regulates the expression of certain genes, providing a role in innate defense and development in animal and plants. This process is used to specifically silence genetic transcripts that encode protein-causing diseases. The therapeutic application of targeted siRNAs is booming given the specificity of gene silencing for a particular protein in a given tissue and the lack of side effects. This new approach to drug discovery is a promising technology that is rapidly moving in the translational research space.

 

About dry eye syndrome

Dry eye syndrome is a multifactorial disease of the tear film and ocular surface that produces symptoms of ocular discomfort, eyesight disorders, and tear film instability with potential damage to the ocular surface. Dry eye syndrome is accompanied by such symptoms as ocular pain, itching, stinging, and irritation of the eye tissues. It is a characteristic disease of developed countries, associated with pollution, air conditioning, the use of contact lenses, refractive surgery and continued use of computers. Moreover, the amount and quality of tears decrease with age. Prevalence is between 5% and 30% among people aged 50 or over, and it is more frequent in women.

 

Dry eye can be treated with cyclosporin drops or autologous serum, but there is as yet no specific product for chronic treatment of the ocular pain related to dry eye syndrome; oral analgaesics or anaesthetics are used in general. However, the main treatment consists of artificial tears, in the form of drops, gel or creams. Preservative-free eye drops have generally been found to offer the best long-term response.

 

About Sylentis

Sylentis, a company of PharmaMar (MSE:PHM), is a biotechnology company fully owned that develops innovative therapies harnessing the technology of post-transcriptional gene silencing or RNA interference (RNAi). Sylentis has developed an approach to efficiently design RNAi-based therapeutics that can be used to silence numerous disease-causing genes. We currently have a robust therapeutic program in ophthalmology with two candidates under development in Phase II studies for glaucoma (bamosiran) and ocular pain (SYL1001)II,III,IV. Sylentis is also developing new products for the treatment of several eye diseases such as ocular allergies and retina diseases. To know more about us, please visit us at www.sylentis.com.

 

Disclaimer

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.


http://www.sylentis.com/index.php/en/news/professional-news/119-sylentis-announces-new-preclinical-and-clinical-data-for-its-syl1001-molecule-during-arvo-2017

Physicists working to cure 'dry eye' disease

Posted by australiandryeye on May 2, 2017 at 11:20 PM Comments comments (0)

The eye is an exquisitely sensitive system with many aspects that remain somewhat of a mystery—both in the laboratory and in the clinic. A U.S.-based team of mathematicians and optometrists is working to change this by gaining a better understanding of the inner workings of tear film distribution over the eye's surface. This, in turn, may lead to better treatments or a cure for the tear film disease known as "dry eye." They describe their work in the journal Physics of Fluids.

Dry eye disease afflicts millions of people worldwide, with symptoms such as pain, dryness, redness, reduced visual acuity, and feelings of grittiness. While drops can provide some temporary relief, dry eye conditions can damage the cornea and, over time, result in reduced visual function.

When the tear film functions properly, a thin liquid film coats the eye surface during a blink by the upper eyelid, creating a smooth optical surface for vision and allowing us to see clearly.

"With dry eye, this optical function is disrupted by either insufficient tear volume or by excessively rapid evaporation of water from the tear film," explains Richard Braun, a professor in the University of Delaware's Department of Mathematical Sciences. "In either case, the tear film may not be able to form a smooth optical interface for a sufficiently long time to allow normal eye function."

The tear film on the surface of the eye is a very thin fluid layer—only a few millionths of a meter thick. This thickness is less than 1,000 times the size of the eye opening, which is approximately 1 centimeter.

Braun and colleagues "took advantage of this difference in sizes to develop simplified mathematical models that work quite well to capture experimentally observed phenomena in vivo," he said.

Once the team created a mathematical model, they were able to solve it using numerical methods in the computer appropriate for solving the equations on irregularly shaped domains like the shape of the exposed area of the eye. "We use and extend a computational framework called 'Overture,' which was originally developed at Lawrence Livermore National Laboratory," Braun added.

Under the assumptions of their model, the team quantified the dynamics all over the exposed ocular surface, and the results agreed well with in vivo observations of the tear film gained from fluorescence imaging. "Our mathematical results captured how tear fluid makes its way around the eyelids to the drainage holes called 'puncta,' in the inside corner of the eye," he said.

Among the team's key findings was verifying that it takes "a blink" to redistribute tear film. "The evaporated tear film on the front of the eye can't be replenished by simply supplying more new tear fluid from the lacrimal gland," Braun noted.

Braun believes their results "may aid in the development of better treatments for dry eye, and also add valuable context and understanding for current imaging techniques used to observe tear film dynamics."

Explore further: Mathematicians model heat flow in human tears

More information: The article, "Tear Film Dynamics with Evaporation, Wetting, and Time-Dependent Flux Boundary Condition on an Eye-Shaped Domain" is authored by Longfei Li, Richard J. Braun, Kara L. Maki, William Henshaw, and P.E. King-Smith. It will be published in the journal Physics of Fluids on May 6, 2014. DOI: 10.1063/1.4871714

Read more at: https://phys.org/news/2014-05-physicists-eye-disease.html#jCp

Could a tear cure dry eyes?

Posted by australiandryeye on May 2, 2017 at 11:15 PM Comments comments (0)

British scientists have patented the design of a biological tear that could be used by millions of people who suffer with eye problems caused by their own tears not working properly.

The most common treatments for dry eyes are lubricants, ointments or artificial tear fluids made from polymers such as methlycellulose (a component of wallpaper paste).

But researchers at Oxford University have discovered the secret of the essential ingredients of real tears, and are working towards developing drops based on the proteins and fats in the real thing.

Most people associate tears with crying, but they play a vital role in the visual system every minute of the day. As well as being a super-efficient cleaning fluid, they sluice foreign objects from the eye, get rid of noxious fumes such as those given off by onions, and provide biological protection from infections.

They also keep the eye clean and moist - working like car windscreen wash-ers every time we blink - and feed the cells of the cornea. Because the cornea has no blood supply, the tears carry oxygen and essential nutrients to the tissue cells and take the waste products away.

A lack of tears can often result from effects of some medications such as anti-histamines, oral contraceptives and antidepressants. Tear production also naturally decreases with age, resulting in dry eyes, which can feel hot and gritty and appear red and swollen.

'Every time we blink, we spread a thin layer of tear over the eye,' says Dr John Tiffany, lecturer and tear researcher at Oxford University. 'Normally the eye blinks pretty rapidly to constantly refresh the tear layer, but when, for example, people stare at a computer screen for a long time, the layer breaks up and that can result in damage.

'Problems such as the air pollution from the general urban environment or as a result of specific working conditions are increasing, and mean that in some cases people have to use eye baths to get rid of the irritation.'

He says eye drops and other products use a variety of artificial polymers but, as yet, there is no completely satisfactory formula for tears.

The researchers are planning talks with pharmaceutical companies about the future development of the Oxford tear. 

Read more: http://www.dailymail.co.uk/health/article-7676/Could-tear-cure-dry-eyes.html#ixzz4fyx8F04Y

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Novartis to strengthen R&D pipeline by in-licensing ECF843 for ophthalmic indications

Posted by australiandryeye on April 9, 2017 at 9:00 AM Comments comments (0)

Novartis exercises an option to in-license ECF843, a recombinant form of human lubricin from Lubris LLC, for ophthalmic indications worldwide (outside Europe)

Dry eye is an area with high unmet medical need, impacting over 344 million patients globally[1]


ECF843 is a new therapeutic approach and potential first-in-class Rx treatment in dry-eye, which in a small phase II study[2] showed the potential to provide instant relief of symptoms and improve signs


This in-licensing will build upon Novartis' leadership in dry eye with global artificial tear products including Systane®, Tears Naturale® and Genteal®


Basel, April 6, 2017 - Novartis announced today that it has exercised an option to in-license ECF843 for ophthalmic indications worldwide (outside Europe). The closing of the deal is subject to customary closing conditions including regulatory approvals. The financial and other terms of this transaction are not disclosed.



ECF843 is a recombinant human lubricin (rh-Lubricin) protein, developed by Lubris LLC, Boston, USA. Instant relief of dry eye symptoms by improving signs in a timely manner remains a high unmet medical need and a relevant factor for patient compliance and treatment success. In a small phase II clinical study[2], ECF843 demonstrated the potential to provide immediate improvement of symptoms likely by increasing lubrication across various eye and tear surfaces together with an improvement in signs of dry eye within 28 days - without reporting treatment-related adverse events.



"ECF843 has the potential to be the first therapeutic to provide rapid relief of dry eye symptoms and significantly improve signs," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Exercising our option to in-license ECF843, along with our recent acquisition of Encore Medical for the treatment of presbyopia, underscores our commitment to treating diseases of the front of the eye which impact millions of people worldwide"



Lubricin protein deficiency is observed in dry eye patients. Lubricin is an endogenous glycoprotein expressed in areas of high shear stress and friction including the tear film where it binds to and protects tissues of the ocular surface, the assumed mechanism that ECF843 addresses. ECF843 is a new therapeutic approach and a potential first-in-class Rx treatment in dry-eye, which is an area of high unmet medical need impacting over 344 million patients globally.[1]ECF843 is hypothesized to restore the tear film function, reduce friction and relieve the signs and symptoms of dry eye.



This in-licensing builds upon Novartis' leadership in ophthalmology and dry eye treatments with a global portfolio of artificial tear products that includes Systane®, Tears Naturale® and Genteal®.



Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "to strengthen," "pipeline," "potential," "builds," "portfolio," "subject to customary closing conditions," "expect," "commitment," "hope," will," "hypothesized," or similar terms, or by express or implied discussions regarding potential completion of the announced in-licensing of ECF843, or regarding potential marketing approvals for ECF843, or regarding potential future revenues from ECF843 and the other products in the Novartis dry eye portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the proposed in-licensing will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that ECF843 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that ECF843 or the other compounds in the Novartis dry eye portfolio will be commercially successful in the future. In particular, management's expectations regarding ECF843 and the other compounds in the Novartis dry eye portfolio could be affected by, among other things, regulatory actions or delays or government regulation generally, including a failure to obtain necessary government approvals for the in-licensing of ECF843, or delays in obtaining such approvals; the potential that any other closing conditions for in-licensing of ECF843 might not be met; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; competition in general; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.



About Novartis Ophthalmology


Novartis is a leading ophthalmology company, with therapies that treat both front and back of the eye conditions, including retina diseases, glaucoma, dry eye and other external eye diseases. In 2016, Novartis combined its retina medicines business with the Alcon pharmaceuticals business, now operating as one Ophthalmology franchise under Novartis Pharmaceuticals.


About Novartis


Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.


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References


[1] Market Scope 2016 Dry Eye Products Report: A Global Market Analysis for 2015 to 2021.

[2] The Ocular Surface, Vol. 15, Issue 1, p. 77-87.


https://www.novartis.com/news/media-releases/novartis-strengthen-rd-pipeline-licensing-ecf843-ophthalmic-indications

Protein agent may change approach to treating dry eye, inflammation

Posted by australiandryeye on March 24, 2017 at 8:15 AM Comments comments (2)

Take-home: Recombinant human lubricin showed potential as a new therapeutic approach to the management of dry eye disease in a small clinical trial. Compared with sodium hyaluronate, lubricin (Lubris BioPharma), significantly improved both signs and symptoms of moderate dry eye after two weeks of treatment.

 

Patients with moderate dry eye disease experienced significant improvement in signs and symptoms following a two-week clinical trial of a recombinant version of the human protein lubricin (Lubris BioPharma) compared to sodium hyaluronate (HA).

 

Although lubricin is still an investigational agent, it shows promise as an innovative approach to preventing or reducing ocular inflammation, said Paul Karpecki, OD, an expert on ocular surface disease.

 

In this randomized, double-masked, parallel group safety and efficacy trial and 1-week follow-up, 19 patients were treated with lubricin 150 µL eye drops and 20 with HA 0.18% eye drops.

 

Subjects receiving lubricin experienced greater than 70% reduction in their symptoms from baseline. Improvements against HA were reported for foreign body sensation (p < 0.013), sticky feeling (p < 0.0432), blurred vision (p < 0.0013), and photophobia (p < 0.011) in at least one eye.

 

Improvements shown

 

Lubricin also demonstrated statistically significant improvements against HA in the following objective signs of dry eye: corneal fluorescein staining (OD/OS: 43.8%, 50.0%, vs. 26.5%, 23.3%, p < 0.0398, p < 0.0232), TFBUT (p < 0.010), eyelid erythema (p < 0.004), conjunctival erythema (p < 0.0013), and daily mean instillations (p < 0.04). No adverse effects related to lubricin were reported during the trial.

 

A key point from the trial was the statistical improvement in both signs and symptoms, Dr. Karpecki said, adding that the improvements in corneal staining, symptoms, and visual acuity amount to a “trifecta,” hinting at the potential of lubricin.

 

Results of the study were published in The Ocular Surface. The study was sponsored by Lubris BioPharma and Dompé Farmaceutici and was conducted at the Policlinico Umberto I, Sapienza University of Rome.

 

The molecule lubricin is one of the most lubricating and adhesive proteins in the body and is found on the ocular surface. It protects tissue surfaces from friction-related damage and wear, but its production may become impaired due to inflammation.

 

The hypothesis behind the development of recombinant lubricin is that by reducing friction it could interrupt the inflammatory cascade and help restore proper function in the treated area.

 

“This is exciting,” said Dr. Karpecki, who is in private practice in Lexington and Louisville, KY. He was not involved in the study. “The new area of interest is going to be proteins.”

 

Lubricin is one of a number of proteins found in tears and one of the most lubricious, making it an important barrier against ocular surface damage.

 

Commenting further on the trial findings, he noted that a small study with about 20 patients in each arm would not ordinarily be expected to produce statistically valid outcomes.

 

“The fact that it did really impress me,” Dr. Karpecki said. “It amazes me that you can get that kind of success with such a small N number, which bodes well for the future of this product.”

Blurred vision outcome

 

One finding that stood out was the day 14 outcome for blurred vision, Dr. Karpecki said, explaining that significant improvement often takes longer. In the left eye, lubricin supplementation achieved a 74.4% reduction from baseline compared to 56.3% in the HA group. However, it will be important to assess the efficacy of lubricin over longer periods in future studies.

 

The study design in which lubricin was compared with HA is also highly relevant, he said. HA is the most prescribed treatment for dry eye in most countries, although not in the United States.

 

“That in itself is fairly bold, to say we’re going to go up against number one and see if we can be equal,” he said. “In this case, they were far superior, and especially with a relatively small number of patients in each group.”

 

 

Paul Karpecki, OD

 

E: [email protected]

 

Dr. Karpecki is a consultant to Lubris BioPharma.


Novel topical peptide for dry eye tackles underlying cause of disease

Posted by australiandryeye on March 24, 2017 at 8:05 AM Comments comments (0)

 

A first-in-class topical synthetic peptide being developed as a treatment for dry eye disease (Lacripep, TearSolutions Inc.) is set to enter into clinical development.

 

The novel proprietary agent, planned to enter a phase I/II trial in March 2017, is a fragment of lacritin, a naturally occurring, eye-selective tear glycoprotein. The agent was discovered in 2001 by Gordon W. Laurie, PhD, professor of cell biology and ophthalmology, University of Virginia, Charlottesville, and chief scientific officer and cofounder, TearSolutions Inc., Charlottesville, VA.

 

“Lacritin is largely released into tears by acinar cells of the lacrimal gland, although it is also produced by other cells, including those of the meibomian gland,” Dr. Laurie said.

 

Findings from laboratory and preclinical research have included collaborators from James Madison University; Eastern Virginia University; Cornell Univesity; University of California, San Francisco; University of Southern California; and University of Western Ontario.

 

 

Tears stimulated

 

Their research has found that the treatment topically stimulates basal tear secretion and wound healing, helps restore ocular surface cells to normal, and is deficient in the tears of persons with various kinds of dry eye disease.

 

“[The agent] has the same properties as the parent molecule, and unlike all existing therapies for dry eye disease, appears to address an underlying cause of the disorder rather than a downstream consequence,” Dr. Laurie explained. “Analogous to insulin treatment for diabetes, [lacritin] essentially represents a replacement therapy to correct an existing deficiency. For that reason, we believe it holds exciting promise as a very safe and effective therapy.”

 

The development history of the agent dates back to 1991 when Dr. Laurie was searching for a research topic at the University of Virginia.

 

“I was struck by the fact that no one seemed to be addressing the biological basis of dry eye disease other than downstream inflammation,” he added.

 

Dr. Laurie approached the National Eye Institute with his ideas. He submitted and received funding to biochemically screen for natural regulators of tear secretion.

 

“Trying to identify this natural tear stimulatory activity was like looking for a needle in a haystack,” he said. “The needle was the novel protein that we named lacritin.”

 

The first lacritin experiments showed it was released by lacrimal acinar cells and promoted tear secretion. In addition, lacritin was found to be important for the health and homeostasis of the ocular surface epithelium as evidenced by its ability to rescue cultured corneal epithelial cells stressed by exposure to inflammatory cytokines.

 

No other tear protein appears to share these properties because the capacity of healthy control tears to rescue inflamed cells was lost when tears were depleted of lacritin,” Dr. Laurie outlined. “Furthermore, tears from persons with dry eye lack lacritin and failed to promote health, but gained this benefit when spiked with lacritin.”

 

Mechanistic studies revealed mitochondrial function was restored. Lacritin was also found to transiently stimulate autophagy, the physiological process that maintains homeostasis by removing damaged proteins and cell organelles which accumulate when cells are stressed, such as by inflammation.

 

“By restoring a more normal ocular surface condition, lacritin appears to remove triggers that give rise to inflammation, thereby breaking the vicious cycle that perpetuates inflammation in dry eye disease,” Dr. Laurie said.

 

Results of preclinical studies in animal models showed lacritin was effective in promoting tear secretion, restoring ocular surface integrity, and reducing focal infiltration of inflammatory CD4+ T cells in lacrimal glands.

 

“In the animal studies, we found these benefits were achieved quickly and were persistent,” Dr. Laurie said.

 

In order to translate lacritin’s benefits into clinical use, the focus turned to creating a synthetic lacritin peptide which is smaller, easy to manufacture, and retains all of lacritin’s known activities. The final therapeutic agent consists of the lacritin C-terminal fragment.

Phase I/II trial plans

 

The first in-human study aims to enroll 201 patients with Sjögren’s syndrome dry eye. Patients will be randomly assigned into 3 groups to receive 1 of 2 doses of the lacritin agent or placebo for 4 weeks at a frequency of 3 times per day.

 

The initial clinical trial is focusing on Sjögren’s syndrome because clinical features are better defined in Sjögren’s dry eye compared with other forms of dry eye, Dr. Laurie said. Therefore, variability that commonly plagues dry eye studies will be reduced.

 

“We expect [the agent to] have benefit across the full spectrum of the condition because lacritin deficiency is apparent in all forms of dry eye,” Dr. Laurie added.

He also noted that although the therapy is administered 3 times daily in the first clinical trial, findings from preclinical studies suggest that once-a-day dosing may be feasible.

 

“We found that [lacritin] remained stable in rabbit tear film for 24 hours,” Dr. Laurie said. “Thus, it may have long acting activity.”

 

Safety is not expected to be a concern because no dose-limiting toxicity was observed in animals, he added.

 

“That is not surprising considering [the agent], like lacritin, is naturally occurring in human tears,” Dr. Laurie said.

 

 

Gordon W. Laurie, PhD

 

E: [email protected]

 

Dr. Laurie is co-founder and chief scientific officer of TearSolutions Inc. He is also an inventor on a number of issued and pending lacritin patents licensed by TearSolutions.


http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/novel-topical-peptide-dry-eye-tackles-underlying-cause-disease

UAB Optometry awarded grant for dry eye research

Posted by australiandryeye on March 7, 2017 at 6:50 PM Comments comments (0)

 

Written by Keaira Turner


Media contact: Alicia Rohan, [email protected]


University of Alabama at Birmingham School of Optometry researchers have been awarded a $1.9 million grant to study potential molecular markers in patients that could predict structural and functional changes of the eye in dry eye disease, and may lead to a targeted therapy.


“Dry eye is the most frequent eye disease that an eye care practitioner sees,” said Jason Nichols, O.D., Ph.D., professor in the UAB School of Optometry and assistant vice president for Industry Research Development in the UAB Office of the Vice President for Research and Economic Development. “The study will look at the lipid layer of the eye and the biochemical changes that cause dry eye. Once we understand these changes, we will be able to better treat the condition that affects up to 30 percent of the world.”


The National Eye Institute-funded study focuses on the impact of one of three layers on the eye, the outer lipid layer, an oil-based layer produced by glands that line the eye, sealing the tear film. The lipid layer helps decrease evaporation of our natural tears and provides a smooth surface needed for optimal vision. The lipid layer is where the problem lies for most people who develop dry eye symptoms.


 

Nichols was recently recognized as a top leader in the contact lens industry by Contact Lens Spectrum.


Nichols looks to target and identity the fatty acids that decrease the tear film, and their structural impact on the eye, using custom-built optical systems capable of measuring the very thin tear film. This study will help determine the functional impact of the lipid layer that increases the evaporation of the thinning tear film, causing dry eye.


 

“We hope to find the specific lipid that has been altered in the lipid layer to be able to provide patients with targeted treatment by either replacing the lipid or fixing the glands so they express the right amount of lipids,” Nichols said.

Boston's Dry Eye Pioneer Donald R. Korb OD

Posted by australiandryeye on March 7, 2017 at 3:50 AM Comments comments (0)

By David Bagdon, Publisher


Dry eyes are not a new phenomenon, in fact; most people have experienced them at various times throughout their lives. In most cases, dry eyes are a nuisance causing minor discomfort often brought about by eye strain or exposure to dry, windy conditions. However, for those suffering from chronic dry eye, the problem can cause significant pain and discomfort that can result in damage to the surface of the eye. It is estimated that over 25 million people in the United States and some 300 million worldwide suffer from dry eye.


Dr. Donald Korb of Korb and Associates, based in Boston, is widely recognized as one of the leading researchers and experts on the matter of chronic dry eye. Dr. Korb has been studying the issue for some 30 years and has published over 100 papers on the topic. As he explains, the issue first came to his attention in 1980 as he was researching and developing extended wear contact lenses.

To his surprise, several subjects in the study showed an unusual intolerance to this type of contact lens which led him to develop a hypothesis that the problem was tied to an oil deficiency on the surface of the eyes. While the accepted belief at that time was that dry eyes were the result of inadequate tear production, Dr. Korb was convinced that dry eye was due to an oil deficiency related to obstruction and dysfunction of the small Meibomian glands that line each eyelid.


When functioning correctly, the Meibomian glands serve to coat the ocular surface with oil to preserve moisture, while dysfunctional ones allow rapid evaporation and the resulting dryness. Dr. Korb teamed up with Dr. Antonio Henriquez of Barcelona, Spain, and the result was the discovery that the affected subjects in the study were suffering from obstructed Meibomian glands which resulted in the contact lens discomfort. Dr. Korb named the condition Meibomian gland dysfunction (MGD).


“What was difficult to believe is that a competent eye doctor could closely examine the eyes and the lids, yet would be unable to determine that the glands were obstructed without special tests utilizing pressure. In our original scientific article we stressed that the condition was not obvious. A thorough review of the non-obvious nature of Meibomian gland dysfunction was published in 2010. The difficulty in making this diagnosis led me to invent a device known as LipiView which is now used routinely to make this evaluation,” Dr. Korb said.


After identifying the problem, Dr. Korb directed his full focus to both research and the treatment of patients dealing with MGD. As he discovered, the Meibomian glands are small and delicate and if they are not producing quality oil, the problem can quickly deteriorate into acute inflammation. Due to his background as a researcher, Dr. Korb was able to rapidly study patient problems that arose in his own practice.


In order to diagnose and treat the problem of MGD on a much broader basis, he co-founded a company called TearScience which not only pioneered the LipiView tear evaluation device, but also produced LipiFlow, a device that simultaneously heats the inner lid surfaces while applying pulsatile pressure in order to improve oil flow and diminish inflammation. To date, the device is being used in over 250 eye care practices with over 100,000 patients having received treatment.


When asked about the significance of his invention, he looks back on that period as both challenging and rewarding.


“LipiFlow has been an exciting experience, perhaps the most exciting of my life. While I have over 20 inventions, 10 of which have been marketed, the complexity of developing the science of thermal pulsation treatment was by far the most complex. Although I have chosen not to be involved with the operation of the business, preferring research and clinical practice, seeing TearScience grow to employ over 100, including 10 engineers, has been like a dream,” he said.


“In addition, having had access to tens of millions of dollars for this research, we’ve had funding for many clinical studies and discoveries which are now in clinical practice to be used by all without fees,” he added. “This could not have been better or more exciting! I regularly receive letters from dry eye sufferers around the world who I have never met; that is a source of great gratification to me.”


Although Dr. Korb’s efforts have helped literally thousands of patients address their MGD and regain ocular comfort, he is concerned about the impact of electronic devices such as smart phones, tablets and computers on future generations. One issue that exacerbates MGD is extended screen time, not just from the standpoint of eye strain, but because it reduces one’s blink frequency, an action that is critical to the distribution of oil on the ocular surface.


According to Dr. Korb, our society’s dependence on electronic devices is likely to result in a dramatic increase in MGD over the coming years. In fact, he indicates he is already seeing an unusual increase in the number of cases involving young people and teens.


“Our group recently published a report in a prestigious journal titled ‘Dry eye is the wrong diagnosis for millions’. The correct diagnosis for over 80 percent of those suffering from dry eye is Meibomian gland dysfunction,” he said. “This is important for the future because the professions must recognize that obstruction of the glands is the usual cause of dry eye and that a key factor in this obstruction is inadequate blinking. It is well documented that excessive screen time dramatically reduces a person’s blink rate.


“In fact, a recent study conducted by our group showed that the incoming class at a prominent health care school already had concerning signs of dry eye. Based on the latter study, which will be published this year, 62 percent had symptoms which worsened as the day progressed, 41 percent were forced to use artificial tear supplements daily, 17 percent had discomfort using a computer, and over 50 percent had significant atrophy and permanent loss of at least 20 percent of their Meibomian glands. Dry eye is on its way to becoming a major public health problem and will only increase unless a government funded task force is enlisted to combat what is already a vocationally disabling disease for many.”


One of the most notable things about the way Dr. Korb addresses problems with dry eye is his very deliberate and methodical approach to diagnosis and treatment. Most likely a product of his background as a researcher, he methodically tests and reevaluates patients over a course of several appointments. In all cases he records copious notes about what is and isn’t improving. He’s quick to point out that dry eye is not something that can be resolved in a single visit. The ability of the eyes to maintain the appropriate amount of moisture depends on a delicate balance of Meibomian oil, adequate tears and proper blinking. Should these factors fall out of balance; the result can be inflammation which often cascades into problems resulting in even more discomfort.


“It is critical for the eye care practitioner to understand that a systematic approach is required to make the correct diagnosis before initiating treatment. While over 80 percent of all dry eye sufferers have meibomian obstruction and dysfunction, it is critical for the doctor to evaluate a minimum of four other factors; the nature of the blink, the efficacy of lid closure when sleeping, the extent of meibomian gland atrophy and the status of the sensory nerves,” Dr. Korb said. “One can treat with LipiFlow, but not achieve success for the patient unless all of these areas are addressed. The patient must understand that there will be homework, analogous to dental care, where office treatment must be supported by brushing and flossing.”


To colleagues and patients alike, Dr. Korb’s tireless work is fueled by a very rare level of passion and commitment. Whether he’s caring for patients or pursuing the next breakthrough in his research, Dr. Korb is a man on a mission. He is a deeply compassionate individual whose desire to learn about this affliction drives him to treat over 100 patients per month while still dedicating a minimum of three days per week to his research.'


When asked why he is so focused on this particular affliction and why he has made it his life’s mission, Dr. Korb is characteristically enthusiastic.


“Truthfully, some 35 years ago when I discovered the role of Meibomian gland dysfunction, I had plans to retire at an age which would allow me to follow my other interests, including working to help children pursue higher education in order to realize their own dreams. I also wanted to research the role of ego in mankind’s progress and failures – I still find this exciting.


“However, with every discovery, with every new publication, and with the creation of treatments, procedures and products for both patients and doctors, it was clear there was much more to accomplish. I still am excited every day by what I do and it is my hope that more can be accomplished to alleviate the suffering of over 30 million people in the USA with dry eye. Frankly, there is no area that provides me with the level of satisfaction and daily stimuli than what I do. I have been, and continue to be very fortunate.”


Korb and Associates is located at 400 Commonwealth Avenue in Boston. The office can be reached at 617-426-0370 or www.korbassociates.com.


http://www.fiftyplusadvocate.com/archives/11475

Mitotech eyes novel approach to treating Dry Eye Disease

Posted by australiandryeye on March 7, 2017 at 3:45 AM Comments comments (0)

An aging population, an ever increasing amount of time viewing digital devices and a growing trend in eye diseases are all factors expected to fuel a global increase in Dry Eye Disease. Currently, there are about 16 million people in the U.S. alone suffering from the condition, which is quickly becoming a common malady.

 

According to the research and consulting firm GlobalData, the global market for treating dry eye is expected to climb to an estimated $4.6 billion by 2024, more than doubling the estimated $2.2 billion market size of 2014.

 

Additionally, Dry Eye Disease has become associated with other conditions like glaucoma, rheumatoid arthritis, Sjogren's syndrome, post-LASIK surgery and patients taking anti-depressants, Dr. Penny Asbell, an ophthalmologist at the Mount Sinai Department of Ophthalmology in New York, said.

 

The condition causes a reduction of tears being produced needed to lubricate and nourish the front of the eye called the tear film. In a normal state, the layer provides the cornea and conjunctiva a healthy barrier from exposure as well as smoothing the anterior surface to provide the best optics for good vision. If the tear film becomes unhealthy and begins to break down symptoms of irritation as well as unstable and intermittently changing vision can happen.

 

Tear production tends to slow as people get older. By the time someone reaches 65 they can lose up to 65% of their tear volume compared to when they were 18. The condition can be exacerbated by medical conditions that begin to present themselves with age as well, by environmental influences like air pollution and windy, dry climates and by use of systemic medications.

 

Yet, it is not exclusive to seniors. Dr. Asbell said more cases are being reported in the young, most likely due to the increasing amount of time they spend looking at computer screens and digital devices that decreases the amount of blinking and lubrication of their eyes suffers.

 

Tears have a fairly intricate composition as they are made up of hundreds of different types of molecules, including natural antibiotics called lysozymes, vitamins, minerals, mucus, oil and water.

 

Dry Eye Disease is a persistent condition, much like chronic pain, that can interfere with quality of life due to constant dry, itchy, gritty feeling and red or swollen eyes. It is seen as a condition that is a multifactorial disease affected by inflammation, tissue degeneration and tear production deficit. It’s also one of the main reasons patients go to see an eye doctor.

 

Currently, there are only two FDA-approved treatments for Dry Eye Disease — Allergan’s Restasis and Shire’s Xiidra, which focus almost exclusively on suppressing inflammatory aspects of the disease.

 

Luxembourg-based Mitotech, which is a clinical stage biotechnology company focused on developing treatments for age-related disorders like Dry Eye Disease, recently received several U.S. patents covering various formulations of its lead compound SkQ1 and its use in ophthalmology.

 

“The interesting thing is that it’s a whole different mechanism improving cellular activity,” Dr. Asbell, who has had first-hand laboratory experience with SkQ1, said. “It’s totally different from Restasis and Xiidra. Both work as anti-inflammatory agents, but SkQ1 improves cellular function and has anti-oxidant effect.”

 

SkQ1 works on a cellular level by reducing damage caused by excessive reactive oxygen species (ROS), which are types of free radicals that play an important role in cell signaling. SkQ1 also selectively protects membrane’s cardiolipin from oxidation and by doing so prevents mitochondrial dysfunction and process of cell death called apoptosis. Another feature of the compound is that its oxidation chemistry allows it to be recycled in the mitochondria, creating a renewable antioxidant. The company has built its clinical development program to leverage SkQ1 across age-related disorders that could include treating neurodegenerative diseases like Parkinson’s and Alzheimer’s.

 

“SkQ1 was developed as an agent fighting a spectrum of age-related diseases at their root, which in our hypothesis is oxidative stress inside mitochondria,” Natalia Perekhvatova, Mitotech’s chief executive, said. “In case of Dry Eye Disease our ophthalmic solution Visomitin has been shown not only to suppress inflammation, but also to protect corneal and conjunctival cells from damage and to promote health of lacrimal glands, therefore addressing the disease from multiple angles.”

 

Mitotech’s program for the treatment of Dry Eye Disease is focused on Visomitin, which is approved in Russia and had a successful Phase II study in the U.S. that indicated statistically significant effect of SkQ1 on both signs and symptoms of dry eye.

 

The company is currently preparing Visomitin for Phase III trials, with a goal of getting the compound before the FDA by 2019.

 

“SkQ1’s innovation is that it is not a ‘me too’ drug,” Dr. Asbell said. “It’s a totally different way of addressing the problem of dry eye.”

http://www.fiercebiotech.com/sponsored/mitotech-eyes-novel-approach-to-treating-dry-eye-disease

New Study for Dry Eye Inflammation

Posted by australiandryeye on March 2, 2017 at 7:55 PM Comments comments (0)

Acthar – An New Drug for Eye Inflammation

 

The American Academy of Ophthalmology did not use the word inflammation in the official definition of Dry Eye until 2004. It took several years after that for Dry Eye to be called a disease instead of a syndrome. Naming is one thing and getting doctors to treat the disease in a new way is another. Then and now some doctors treat dry eye disease with artificial tears hoping that lubrication will help instead of treating the inflammation. I realized in 2000 that Dry Eye was due to inflammation and could be helped by anti-inflammatory treatments like cyclosporine drops and Intense Pulse Light. I encountered resistance to my treatment ideas but eventually eye doctors began seeing the benefits of anti-inflammatory treatments. More and more medications that have been used for systemic inflammation are finding a place in ocular inflammation. We have had a growing number of patients with chronic inflammatory conditions that are affecting the eye and more specifically the ocular surface. These patients have an allergic our autoimmune disease that is causing the glands that produce our tear to malfunction. Some medications have helped these patients like oral and topical steroids but the side effect profile is high. We are beginning a study using a different type of anti-inflammatory medication, Acthar.

 

For many people with chronic inflammation, ocular or otherwise, steroids are a way of life. Because their bodies are mistakenly attacking their own organs, steroids must be used to tamp down the response to avoid damage. In the eye, unchecked inflammation can lead to cataract, glaucoma, and even blindness.

 

Inflammation is different than infection. Inflammation means that the body’s natural defenses have been triggered by something (surgery, trauma, or an infection) and a cascade has begun of cells and chemicals in order to fight it. Inflammation alone does not require antibiotics. Infection generally implies that there is some agent (bacteria, parasite or virus) that is causing a problem and usually triggers inflammation as well. Antibiotics might be appropriate here.

 

Inflammation of the eye can occur at any level: keratiis, scleritis, retinitis and uveitis which can be anterior, posterior or in the middle (pars planitis). There are many diseases that can be associated with eye inflammation like multiple sclerosis, Crohn’s disease, irritable bowel and psoriasis.

 

Topical and oral steroids have been the mainstay of ocular inflammatory treatment for decades but keeping patients on them long-term is not ideal because of the many side effects that can occur like bone loss, gastric ulcers and fluid retention. Now, a drug that has long been approved for use in systemic inflammatory conditions like lupus, MR, sarcoid and rheumatoid arthritis is being used for severe allergy and other inflammatory eye conditions.

 

How does it work? Acthar contains the hormone ACTH (adrenocorticotropic hormone) which stimulates your own body to produce more natural steroid hormones so that patients can reduce or eliminate the need for additional steroids or other immunosuppressants like methotrexate or cyclosporine. Unlike steroids, Achthar uniquely binds to a specific receptor (melanocortin) to help down regulate both inflammation and the signals that keep inflammation going once started. These receptors are found on 5 different types of immune modulating cells throughout the body including T-helper and T-regulatory as well as macrophages and dendritic cells. Achthar is given as an in-home injection similar to insulin treatments once or twice week as needed.

 

Besides uveitis, Inflammation is at the root of many ocular diseases and conditions. Acthar is currently being studied for many inflammatory diseases including optic neuritis. Dry eye disease are also caused and perpetuated by inflammation. If you have moderate to severe dry eye and are looking for relief, Toyos Clinic is currently recruiting subjects for free treatment with Acthar to learn more about how this exciting new medication might help to relieve the signs and symptoms of dry eye.

http://www.toyosclinic.com/eye-news/new-study-dry-eye-inflammation-acthar

Eyepowerment by Allergan

Posted by australiandryeye on March 2, 2017 at 4:05 AM Comments comments (0)

Research shows we read emotions in each other’s eyes – that’s the power of eye language. But common symptoms of Chronic Dry Eye disease like red, itchy, burning eyes may be sending the wrong message, one you don’t intend. 

Chronic Dry Eye (CDE) is a medical disease that, over time, can decrease the eye’s ability to make and/or maintain sufficient quality and quantity of tears for a healthy tear film. Up to 33 million people in the United States suffer from symptoms of CDE.

Visit www.eyepowerment.com for more information.



Burning Eye Syndrome: Do Neuropathic Pain Mechanisms Underlie Chronic Dry Eye?

Posted by No More Tears on July 11, 2016 at 4:40 AM Comments comments (0)

Burning Eye Syndrome: Do Neuropathic Pain Mechanisms Underlie Chronic Dry Eye?

 Abstract

OBJECTIVE:

Dry eye is a multi-factorial disorder that manifests with painful ocular symptoms and visual disturbances, which can only be partly attributed to tear dysfunction. This disorder may also involve neuroplasticity in response to neuronal injury. This review will emphasize the key characteristics of dry eye pain and its pathologic mechanisms, making the argument that a subset of dry eye represents a neuropathic pain disorder of the eye, more appropriately called "burning eye syndrome."

METHODS:

A literature review was conducted using a PubMed search focusing on dry eye, corneal nociception, and neuropathic pain. Articles were reviewed and those discussing clinical course, pathophysiology, and neuronal regulation of chronic ocular pain as related to dry eye were summarized.

RESULTS:

We found that there is a discordance between ocular pain and dryness on the ocular surface. Although tear dysfunction may be one of the initial insults, its persistence may be associated with repeated ocular sensory nerve injury leading to an acute-to-chronic pain transition associated with neuropathologic changes (peripheral and central sensitization), neuronal dysfunction, and spontaneous ocular pain.

CONCLUSION:

Dry eye is becoming a major health concern due to its increasing incidence, significant morbidity, and economic burden. Recent evidence suggests that a subset of dry eye may be better represented as a chronic neuropathic pain disorder due to its features of dysesthesia, spontaneous pain, allodynia, and hyperalgesia. Future therapies targeted at the underlying neuroplasticity may yield improved efficacy for patients with this subset of dry eye, which we term "burning eye syndrome."

© 2015 American Academy of Pain Medicine.

SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study

Posted by No More Tears on July 6, 2016 at 5:10 AM Comments comments (0)


Introduction

 

This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms.

 

Methods

 

In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled the study drug twice daily and recorded dry eye symptoms daily. Subjects were randomized 1:1:1 into one of three ophthalmic solution treatment groups: SkQ1 1.55 µg/mL, SkQ1 0.155 µg/mL, or 0.0 µg/mL (placebo). Subjects were exposed to a controlled adverse environment chamber at 3 of the 4 study visits (Day −7, Day 1, and Day 29). Investigator assessments occurred at all study visits.

 

Results

 

SkQ1 was safe and efficacious in treating dry eye signs and symptoms. Statistically significant improvements with SkQ1 compared to placebo occurred for the dry eye signs of corneal fluorescein staining and lissamine green staining in the central region and lid margin redness, and for the dry eye symptoms of ocular discomfort, dryness, and grittiness. In addition, SkQ1 demonstrated greater efficacy compared to placebo, although the differences were not statistically significant, for corneal fluorescein staining in other regions and/or time points (total staining score, central region, corneal sum score, and temporal region), lissamine green staining for the central and nasal regions, and blink rate scores.

 

Conclusions

 

This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results.