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Help from the Stomach for Dry Eye

Posted by australiandryeye on August 5, 2017 at 4:30 AM Comments comments (0)


After a long day of working at the computer, scratchy contact lenses are not only painful, over longer periods of time they can also damage ocular tissue. Relief may be in sight from a natural mucus component referred to as a mucin. A team from the Technical University of Munich (TUM) has now succeeded in demonstrating that contact lenses coated with purified porcine gastric mucin do not cause damage to the eye anymore.

 

Mucins are molecules capable of binding lots of water, thus they can act as a natural lubricant. Our tears contain such mucins, which also occur in the mucous layer protecting the stomach and intestines. The tear fluid of patients suffering from dry eyes usually does not contain enough of this molecular lubricant, the mucin MUC5AC.

 

Such a lack of MUC5AC can be problematic in particular for those of us who wear contact lenses: Without a protective lubricant film between the eye and the contact lens, the tissue of the cornea can be injured. Thus, a group of scientists led by Prof. Oliver Lieleg, professor for Biomechanics and head of the "Biopolymers and Bio-Interfaces" lab at the Munich School of BioEngineering, had the idea to apply the missing mucin directly to the contact lens.

 

Mucin coating prevents tissue damage

 

For their experiments, the researchers needed large quantities of the molecule, which eliminated human tears as a possible source. Therefore, the team optimized a method for isolating the necessary mucin MUC5AC from the stomachs of pigs. The chemical structure of this pig mucin is very similar to the human molecule. The purification procedure has to be conducted carefully to ensure that the purified molecule retains its characteristic property as a lubricant and does not suffer from chemical changes during the purification process. "Most of the commercially available mucins, which are already used e.g. for the treatment of oral dryness, have lost exactly this ability; we were able to demonstrate this in a series of experiments. These commercial mucins are therefore not suitable for treating dry eyes," Lieleg explains.

 

In experiments with porcine eyes they tested how their lab-isolated mucins affected the performance of contact lenses. Oliver Lieleg's team was able to prove that the lenses caused no tissue damage when they were coated with mucins. "We showed that the mucin passively adsorbs to the contact lens material and forms a lubricating layer between the contact lens and the cornea," explains Benjamin Winkeljann, first author of the study. Thus, in the opinion of the scientists, it should be sufficient to soak the contact lenses overnight in a mucin solution to obtain the protective effect.

 

Long-term protection without applying eye drops

 

The mucin coating offers several advantages: Conventional products for treating dry eyes are primarily based on hyaluronic acid. However, in contrast to mucin, this molecule does not occur naturally in the tear fluid. Also, hyaluronic acid has to be applied to the eye in the form of drops, requiring repeated applications throughout the day. Mucin, on the other hand, adheres directly to the contact lens, thus providing the eye with long-term protection. Before it is ready for application in humans, the pig stomach mucin will undergo further testing in the lab.


https://www.sciencedaily.com/releases/2017/08/170801094332.htm

Dry Eyes Deserve Attention

Posted by australiandryeye on August 5, 2017 at 4:25 AM Comments comments (0)


Putting carboxymethylcellulose sodium in one’s eyes two, three or more times a day may not sound like a great experience. But I can assure you that it can be. Drops of this chemical, called a topical lubricant, help to keep my eyes from burning, avoiding bright lights, becoming red and itchy, and generally feeling miserable.

 

Like tens of millions of Americans, especially women older than 50, I have dry eye disease, medically known as keratoconjunctivitis sicca. Fortunately, my problem is not severe, certainly not as bad as that of an elderly woman I know who has to use a nightly ointment of mineral oil and Vaseline, which minimizes the dryness but temporarily blurs her vision.

 

The drops I use, an over-the-counter preservative-free product called Refresh Plus (also sold as generic store brands) that I carry with me at all times, are a crucial measure I take to keep my eyes from becoming overly dry and chronically irritated — but not the only one.

 

To minimize the drying effect of wind when driving, cycling or sitting in a room cooled by a fan or air-conditioning, I wear wraparound glasses even when I don’t need them to see clearly. Watertight goggles are de rigueur when swimming, even in fresh water. And I refresh my eyes with drops when I watch a movie, work long hours at the computer, or do any activity that depresses the frequency of blinking, which moistens the eyes.

 

Dry eye is sometimes referred to as “a nuisance complaint — it’s not the sexiest of eye problems,” Dr. Rachel Bishop, chief consulting ophthalmologist at the National Eye Institute, told me. Nonetheless, she said, “Dry eye disease deserves serious professional — and personal — attention. It can be very debilitating and seriously diminish a person’s quality of life.”

Read more at:

https://www.nytimes.com/2017/07/31/well/no-crying-over-dry-eyes.html


New dry eye drug is first that aims to treat cause, rather than symptoms

Posted by australiandryeye on July 13, 2017 at 6:25 AM Comments comments (0)

University of Virginia Health System researchers have developed a potential therapeutic treatment for dry eye, with human testing to start in March. The drug differs from other treatments of dry eye in that it aims to treat the cause of dry eye instead of masking the symptoms.


The drug, trademarked as "Lacripep," is a topical eye drop that functions differently from conventional approaches. Rather than seeking to suppress inflammation – an approach with mixed results – Lacripep aims to eliminate inflammatory triggers by restoring the natural basal tearing mechanism and health of cells in contact with tears. This includes restoration of the nerves on the cornea of the eye, which signal the brain to produce more tears. It also stabilizes the tear film that in dry eye is very unstable.


Each dose of Lacripep remains in tears rather than being washed away, explained its developer, UVA dry eye research specialist Gordon Laurie of the UVA School of Medicine's Department of Cell Biology.


"Most ophthalmic drugs are washed away right away, but that's not the case here. Lacripep is still in the tears 24 hours later, because it goes into the lipid layer and apparently comes out of the lipid layer slowly to treat the eye," Laurie said.


Dry eye affects between 5 percent and 9 percent of the population, with that number increasing to around 35 percent in older women. The condition can occur due to hormonal imbalances, malfunctioning aqueous tear production or lipid production, and general inflammation of the eye. Current treatments aim to suppress the pain and damage caused by dry eye, including steroids to control inflammation, antibiotics and artificial tears.


But these are temporary fixes that do not treat what may be the root cause of the disease – a shortage of the tear protein lacritin – and often lead to frustration and pain for people with the condition. Lacripep is a short synthetic fragment of lacritin. If successful, Lacripep would be the first drug to treat that cause of dry eye.


"We think that dry-eye disease may be much simpler than people have thought in the past, sort of like insulin and type I diabetes," Laurie said. "With lacritin deficient in dry-eye tears, topical Lacripep is a replacement therapy, which will probably not cure the disease. You would still have to keep treating your eyes, but maybe just once a day."


The small-scale clinical trial, called a Phase I/II clinical trial, will begin in March at 25 clinical sites nationwide. More than 200 patients will be recruited. The patients will use two different dosages of Lacripep or placebo three times daily for four weeks. If safe and effective, testing will then expand to a much larger Phase III trial. Should that prove successful, the Food and Drug Administration could consider making the drug available as a treatment.


Laurie's Charlottesville company, TearSolutions Inc., has contracted with Lexitas Pharma Services in Durham, North Carolina, to run the clinical trial. The first trial will accept only patients with Sjögren's syndrome dry eye.


https://medicalxpress.com/news/2017-01-eye-drug-aims-symptoms.html

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

New Dry Eye Web Store Coming Soon!

Posted by australiandryeye on June 9, 2017 at 12:20 AM Comments comments (1)

AustralianDryEye is currently in the process of developing new webstore to retail products specifically for the needs of dry eye patients.


Stayed tuned for updates.

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

Novaliq to study novel dry eye treatment

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

Novaliq announced plans to develop a treatment for ocular neuropathic pain and inflammation in individuals with dry eye disease.


The treatment is being developed in collaboration with the University of Cologne, Germany, the company announced in a press release. 

Dry eye disease (DED) with neuropathic ocular pain is frequently underserved, according to Novaliq. Molecules attempting to target the cannabinoid receptor system are often unstable in water-based formulations, but Novaliq’s EyeSol drug delivery system, which takes poorly soluble drugs and turns them into effective therapies, may help with the bioavailability, stability and efficacy of the cannabinoid-receptor targeting agents, the company said.


“Increasing evidence is available on the importance of neuropathic ocular pain in DED. Based on solid results of our ongoing test series we expect a significant impact of Novaliq’s first-in class Nov-07 program in comparison with existing DED drugs on an established DED mouse model,” Philipp Steven, MD, of the Ocular Surface Group at the department of ophthalmology, University of Cologne, Germany, said in the release. 

“We are now translating evidence from our experimental model into final, conformational studies in close cooperation with Novaliq for a phase 1 clinical study in the near future. Based on the preclinical results, we believe that the Nov-07 program will facilitate the treatment of [dry eye disease] utilizing a dual mode of action toward inflammation and ocular neuropathic pain.”


http://www.healio.com/optometry/business-of-optometry/news/online/%7B8d03abb1-75cc-4f68-b3de-fa9f6f4d60ca%7D/novaliq-to-study-novel-dry-eye-treatment

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

Allergan receives FDA approval for electrical dry-eye device

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

 


Allergan has gotten Food and Drug Administration approval to market its TrueTear Intranasal Tear Neurostimular, a device the company says increases tear production using electrical stimulation.


Allergan, with headquarters in Dublin and New Jersey, has a unit in Irvine, where it was previously based until it was acquired for about $70 billion by Dublin-based Actavis Plc.


TrueTear, Allergan said in a statement, is the first FDA-approved device to increase tear production in adult patients using neurostimulation. The handheld stimulator includes disposable tips that are placed in the nasal cavity, which induces tear production.


“TrueTear represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and drug-free way to temporarily increase tear production,” David Nicholson, chief research and development officer, at Allergan, said in a statement. “As an innovator in eye care, we are continually looking for new products to offer through our portfolio, and TrueTear represents the next step forward.”


Allergan has long been rooted in the eye care industry. In the early 1950s, it developed eye drops to treat allergies and acts as decongestants.

http://www.ocregister.com/2017/05/01/allergan-receives-fda-approval-for-electrical-dry-eye-device/

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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Not all MGD is dry eye

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

"The prevalence of asymptomatic MGD is likely higher than we all realize. If we can find MGD and treat the anatomy early, we can save functioning glands and put the patient in a better position to have a healthier tear film long term. Regrettably, a recent survey of practitioners showed that only 30% routinely screen for MGD. Furthermore, work from our own group at Duke is showing that a large percentage of patients coming in for preoperative evaluation have underlying dry eye and MGD.


Screening is now the practice of the leading few, not the majority. I can only hope we recognize as a whole that screening is critical."


Read more at: http://www.healio.com/ophthalmology/cornea-external-disease/news/blogs/%7B01048fb5-5472-4197-95b6-b7249dd67190%7D/preeya-k-gupta-md/blog-not-all-mgd-is-dry-eye

Nicox first quarter 2017 business update and cash position

Posted by australiandryeye on May 2, 2017 at 11:05 PM Comments comments (0)


Resubmission to the U.S. FDA, by Nicox, on March 8, 2017 of the NDA for ZERVIATE (cetirizine ophthalmic solution) 0.24%, Nicox’s novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.


http://www.nicox.com/news-media/nicox-first-quarter-2017-business-update-cash-position/

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.


Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis (link is external)


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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.



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