Oculis plans to complete pre-clinical studies for its dry-eye candidate, OC301, before year-end 2015, with phase I and phase II pilot studies conducted in 1H 2016.
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Our researchers are now investigating whether bacteria might be the key to unlocking the mystery of dry eye and developing better treatments. They are looking into the microbial community that inhabits the eye’s surface, the ‘ocular microbiome’, to determine if it plays a role in the development of MGD. A change to the balance of this ‘commensal’ community may lead to eyelid inflammation, changes to the composition of the eye’s tears or to the quality of meibum produced by the gland. We are developing a ‘dry eye’ over-the-counter (OTC) drop that will protect against bacterial disruption and help maintain a healthy tear layer. This would be the first such product on the market that seeks to address the aetiology of dry eye.
Statins have known cholesterol-lowering and immunomodulatory properties, which prompted the novel idea of utilising them as a topical ocular therapy. This is the first eye drop to address all the underlying aspects of Blepharitis, which is an inflammation of the eyelids with increased abnormal cholesterol production. The new eye drop decreases cholesterol production and down regulates pro-inflammatory cytokines, thereby improving tear film stability and reducing inflammation. Find out more information.
Preclinical studies reveal that a single topical dose of Lacritin naturally promotes basal tearing without irritation that lasts for hours. After multiple daily doses, elevated natural basal tearing is sustained one week later. Lacritin is also protective against inflammatory cytokines. Corneal staining is reduced to background and lacrimal gland inflammation is diminished. No other tear protein, nor dry eye drug, displays these properties. Find out more.
SYL1001 is a chemically synthesized small interference RNA (siRNA) inhibitor of the Transient Receptor Potential Vanilloid-1 (TRPV1) formulated as eye drops. This receptor mediates pain sensation in the eye. SYL1001 belongs to a new emerging drug class whose mechanism of action differs from traditional small-molecules. Find out more.
Lubricin, which is naturally found on the ocular surface, may play an important role in eye health and comfort by preventing friction between the cornea and conjunctiva which reduces shear stress (such as during eye blinking) to prevent eye injury at the corneal and ocular surface. In patients suffering from moderate to severe dry eye, lubricin is diminished and the act of blinking causes significant discomfort. Topical administration of recombinant human lubricin may provide superior reduction in the signs and symptoms of dry eye disease compared to existing treatments by preventing friction and wear on the ocular surface and restoring homeostasis to the tear film
Pharmaleads is currently completing the evaluation of PL265 for the treatment of ocular pain and dry eye syndrome in animal models. Pharmaleads conducted pharmacology studies with PL265 evaluating the product for the management of ocular pain and dry eye syndrome in collaboration with The Vision Institute in Paris, France. The study assessed the anti-nociceptive effect of PL265 in experimental models of ocular pain / dry-eye syndrome. These pharmacological studies evaluated both mechanical and chemical cornea sensitivities of experimental models in response to corneal injury and inflammatory pain after a five-day treatment with a drop of either PL265 (at a 10 mM concentration) or of phosphate-buffered saline (PBS) in the right eye, twice a day. The results of these studies provided the first evidence that PL265 is highly effective in decreasing ocular pain after various experimental corneal lesions. The study also revealed the novel anti-inflammatory properties of the drug. It also showed that the drug has no anaesthetic properties in the absence of corneal injury.
The objective of our program is to advance a topical ophthalmic analgesic that reduces ocular discomfort associated with dry eye by targeting a voltage-gated sodium channel in the cornea, NaV1.7, and reducing corneal pain. Our product has the potential to be broadly effective in the ~30 million Americans suffering from dry eye regardless of the etiology because it addresses the discomfort rather than the heterogeneous physiologic cause. The analgesic would complement therapeutics that reduce inflammation or improve tear film, allowing the patient to be comfortable over weeks to months required for these therapies take effect. It would also be a useful treatment for postoperative pain following certain surgical procedure and acute ocular injuries, such as corneal abrasion.
OCU310 is a differentiated, topical therapy being developed as a treatment for chronic dry eye disease. It is a proprietary ophthalmic suspension that combines the anti-nociceptive and anti-inflammatory properties of brimonidine, an FDA-approved drug, with a low dose of loteprednol etabonate. Ocugen is able to leverage the FDA’s accelerated 505(b)(2) regulatory pathway, which enables OCU310 to advance rapidly to pivotal clinical studies after establishing initial human proof of concept. If approved, OCU310 is expected to have significant advantages compared to currently marketed products for chronic dry eye disease due to the unique properties of its two active ingredients, including a more rapid onset of action, alleviation of ocular pain and photophobia, as well as a rapid reduction in surface swelling and discharge.
rhNGF, an investigational molecule of recombinant human Nerve Growth Factor (NGF), currently being evaluated for the treatment of eye diseases such as neurotrophic keratitis and retinitis pigmentosa. Results of an open-label clinical study exploring the compound’s safety and tolerability in patients with dry eye disease have recently become available and Dompé will soon initiate a multicentre Phase II study evaluating the safety and efficacy of rhNGF for the treatment of dry eye disease.
The lipid layer is crucial to good vision and corneal integrity. It consists of a complex mixture of lipids which are generated form the lacrimal (tear) gland and the Meibomian glands in the eyelids (Tear and Meibum Lipidomes). Importantly, all of these lipids are present in Lamelleye (CXB/1-14). Given the importance of these lipids to the tear film, Lamellar has created an extensive research program with Glasgow Caledonian Vision Sciences.
P-321 Oophthalmic Solution, is a novel inhibitor of ENaC, which blocks the loss of tears through the absorptive pathway. In multiple pre-clinical models of dry eye, ENaC inhibitors have demonstrated the ability to essentially restore and maintain normal tear volume. Parion has completed a phase 1/2a clinical study in 53 patients with dry eye disease and is pursuing the next steps in the clinical development for this program.
The company develops novel pharmacological treatments for the treatment of DED, based on the manipulation of the neural mechanisms that regulate the volume of tear fluid secreted by the lacrimal glands, and evoke the discomfort sensations elicited by ocular surface dryness, the two main mechanisms that are impaired in DED and are responsible of the signs and symptoms observed in DED patients.
Topical eye treatment for daily use by post-menopausal women Our first product candidate is based on a naturally occurring, endogenous molecule found in the body. In prior clinical trials, the molecule, when used as an active pharmaceutical ingredient, was found to be associated with the mechanism of tear film production. Redwood proposes to restore the natural levels of this molecule by administration by way of an eye drop. This treatment is thought to promote tear film production which is needed to properly lubricate the front of the eye. The Redwood team and other scientists have already confirmed the significant correlation between this active substance and its subsequent reduction of symptoms of Dry Eye Disease (DED) in human clinical trials.
TopiVert’s NSKIs promise to deliver long-term efficacy, improving both signs and symptoms of dry eye disease by effectively treating the underlying inflammation. TOP1630, the Company’s lead NSKI for ophthalmology, has demonstrated an excellent activity profile in in vitro and in vivo pre-clinical inflammatory models where it was shown to be potent and have a fast onset of action. When administered as eye drops, TOP1630 is taken up and retained by target inflammatory cells in the cornea but has minimal systemic absorption, making it an ideal topical eye therapy. TopiVert has received US Food and Drug Administration (FDA) approval for its IND application for TOP1630 in the treatment of DES and a Phase 1/2a proof-of-concept is due to start in the US in early 2017, with results anticipated in the second half of the year.
RGN-259 ophthalmic solution is formulated as thymosin beta 4 preservative-free eye drops for the treatment of both dry eye syndrome and neurotrophic keratopathy. Thymosin beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in all tissues and in all nucleated cells. In the eye, Tβ4 promotes corneal epithelial cell migration, decreases both inflammation and apoptosis, and accelerates both repair and regeneration
Voclosporin, an investigational drug, is a novel and potentially best-in-class CNI with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses, and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile and potential for flat dosing compared to legacy CNIs. Aurinia is committed to working in areas of high unmet medical need and is currently advancing voclosporin for the treatment of lupus nephritis (LN) and focal segmental glomerularsclerosis (FSGS). Additionally, we are advancing voclosporin ophthalmic solution (VOS) for the treat of dry eye syndrome (DES).
The two lead compounds, OC-01 and OC-02, are highly selective nAChR agonists and are being developed for the treatment of signs and symptoms of Dry Eye Disease. The innovative therapy is developed to leverage the Trigeminal Parasympathetic Pathway (TPP) to activate the glands that comprise the lacrimal functional unit (LFU) and promote tear film production. These compounds are being developed in a nasal spray vs. topical eye drop. Utilization of a nasal spray facilitates a convenient access into the nasal cavity, targeting local delivery of the drug compound to activate the Trigeminal Parasympathetic Pathway (TPP), promoting tear film production. OC-01 and OC-02 are currently in Phase 2 trials to evaluate their potential as treatments for the signs and symptoms of Dry Eye Disease (DED). Both candidates have been well-studied in other disease areas, allowing for the rapid advancement of clinical trials. Evaluating the compounds in parallel offers Oyster Point the opportunity to determine which compound offers the better product profile and increases the likelihood of regulatory and commercial success.
KPI-121 is a novel nanoparticle formulation of loteprednol etabonate utilizing Kala’s proprietary MPP technology to enhance penetration into target tissues of the eye. KPI-121 has been studied in multiple clinical trials, including 1% and 0.25% formulations for the treatment of post-surgical ocular inflammation and pain and a 0.25% formulation for dry eye and Meibomian gland disease.
Tavilermide is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye responsible for the maintenance of corneal nerves and epithelium. Tavilermide is differentiated from other investigational therapies in dry eye disease because it induces the production of mucin, a naturally occurring component of the tear film, and works upstream prior to inflammation.
KPI-190 is a part of the ShK family and is being developed as an eye drop for use in several eye diseases including uveitis and Dry Eye Syndrome (DES).
Pathogenic T cells have been shown to play a role in autoimmune eye disease as T cell infiltration and cytokine and chemokine production lead to tissue damage in the eye. Kv1.3-HIGH autoreactive TEM cells have been identified in uveitis and DES making these conditions a good option for development of KPI-190.
AC-120 is an eye drop that targets morning eyelid swelling (also known as ‘puffy eyes’), a common complaint of aging individuals, particularly women, and a condition with a range of different causes. In a Phase 2 clinical program conducted by Aciex and Ora, treatment with AC-120 led to a reduction in morning eyelid swelling with results that showed statistical significance. AC-120 was also well tolerated, with no adverse effects noted
INF101 was shown to inhibit the production of a cytokine involved in dry eye syndrome via a novel mechanism of action. Moreover, INF101 was shown to effectively prevent the retinal damage induced in an experimental model of uveitis in rats in vivo with an efficacy similar to corticosteroids. Due to its different mechanism of action INF101 is not expected to increase intra-ocular pressure, a potentially severe side effect of corticosteroids, and could thus become the front line therapy in dry eye and uveitis sparing corticosteroids for more severe cases.
Quorum Innovations (“QI”) is building a biopharmaceutical company driving one of the next important eras in medicine by engaging the body’s immune system to treat a broad range of pathogens in biofilm form (i.e., surface-attached). Founded on the vision that extracts from the human microbiome can yield microbiome pharmaceutical candidates and human biofilm immunotherapeutics, QI research and development is expected to help solve the problem of antibiotic resistance.
Cyclosporine A is an immunosuppressant that works by inhibiting the interleukin 2 activation of lymphocytes and thus it reduces the attack on the exocrine epithelia of the lachrymal glands; this results in increased tear secretion and increased tear film stability. Cyclosporine A also decreases apoptosis and thus increases the density mucus producing goblet cells, leading to a restoration of the damaged ocular epithelium. In Dry Eye patients, cyclosporine A is effective and it works by increasing ocular surface goblet cell density and tear fluid volume from the accessory lachrymal glands A meta analysis of 1660 participants in 12 trials revealed that topical cyclosporine A is effective in improving the symptoms of Dry Eye Syndrome patients Cyclosporine A is an extremely hydrophobic drug and therefore commercial formulations are based on oil-in-water emulsion. NM133 offers a completely new approach to the delivery of such compounds. Using the patent protected Molecular Envelope Technology (MET) NM133 effectively wraps and solubilises cyclosporine A in a protective cover, helping it across the epithelial barriers of the eye. The technology is applicable to other compounds and additional products are in development for undisclosed indications.
Our goal is to develop a novel L. lactis probiotic-based therapeutic for the treatment of Sjgren's Syndrome (SjS). SjS is a progressive, chronic autoimmune disease characterized by inflammatory cell infiltration of the salivary and lacrimal glands, resulting in acinar epithelial cell atrophy, cell death, and loss of exocrine function.
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 (formerly NS2), is an aldehyde trap in development for allergic conjunctivitis, anterior uveitis, and other forms of ocular inflammation, as well as for Sjögren-Larsson Syndrome and Succinic Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of aldehyde metabolism.
Eye RepairRX ® contains hyCURE® hydrolyzed collagen and its many positive attributes for eye health, safely and effectively. The eye drops can be formulated as a “lubricating eye drop” (and as such a combination of glycosaminoglycans, hyaluronic acid and PSGAG, may be added to the formula) or per FDA CRF 21 as a human ophthalmic drug eye drop for OTC use.
DexaSite™ (ISV-305), a DuraSite formulation of 0.1% dexamethasone, is in Phase 3 development for the treatment of ocular surface inflammation (e.g.,blepharitis), and for the treatment of ocular pain and inflammation in cataract surgery
Coversin may also be applicable as a treatment for other diseases such as Sjögren’s syndrome, the inflammatory disease known for triggering dry eye and dry mouth along with other symptoms. In the autoimmune attack that causes Sjögren’s, disease-fighting white blood cells target glands that produce moisture—primarily the lacrimal and salivary glands. For the dry eye symptom, Coversin can be adapted into a topical ocular treatment, once again making self-administration possible. A 60-day topical eye toxicology study has been successfully completed and there is evidence Coversin has activity against eye surface inflammation. Coversin has successfully completed a 60 day topical eye toxicology study, and there is evidence that Coversin has activity against eye surface inflammation. Delivery by the topical ocular route, made possible by Coversin’s small molecular size, has considerable advantages both in reducing the total quantity of drug needed and, because the very small topical dose, virtually abolishes the effects of systemic complement inhibition, in reducing the risk of meningitis infection or need for prophylaxis of potential Neisseria infections.
BRM421. PDSP is a peptide drug molecule discovered by a research group at a medical center in Taiwan and BRIM has exclusive worldwide rights for PDSP program. PDSP possesses neurotrophic activities to enhance cell proliferation in wound healing and tissue regeneration. PDSP will be developed as topical and injectable products according to its clinical application and patient needs.
BRM421 is the project of developing PDSP for topical ophthalmic applications such as dry eye disease. BRM421 has demonstrated its efficacy in dry eye and corneal wound healing animal models. BRM421 can effectively repair corneal injury, and enhance proliferation of limbal epithelia stem cells in the mouse model. The IND-enabling package is under preparation and BRIM is planning to file the IND in the US by the end of 2016.
BL-1230 is a potent and selective cannabinoid receptor type 2 (CB2R) agonist intended as a novel treatment for Dry Eye Syndrome (DES). DES is a disease resulting in dryness, tear film instability, irritation, redness, itchy feeling, eye fatigue and even blurred vision, with potential damage to the ocular surface. The involvement of CB2R in immune modulation is well established, and pre-clinical studies in three ocular inflammatory models have demonstrated that BL-1230 eye drops have significant anti-inflammatory activity, which attenuates the pathology and improves histological outcomes
Lupuzor™ is a potentially breakthrough treatment for lupus, having recently began phase III in Europe and the U.S. under a Special Protocol Assessment (SPA) and Fast Track designation from the U.S. FDA. ImmuPharma holds all worldwide rights of this lead compound. Lupuzor™ was invented at the Centre National de la Recherche Scientifique, (CNRS) in France, Europe's largest fundamental research insitution with which the ImmuPharma group has a long-standing collaboration. Lupuzor™ has undergone substantial testing, including preclinical development, phase I, phase IIa and phase IIb.
ADP355 is a peptide that mimics the action of adiponection by binding to the same receptors as the native protein. Activation of these receptors leads to a broad anti-inflammatory response, resulting in down-regulation of both pro-inflammatory cytokines and inflammatory cellular activity in a number of organ systems. In an animal model of dry eye disease, ADP355 has been shown to reduce the levels of pro-inflammatory cytokines and inhibit activated T cells on the ocular surface, leading to a significant improvement in tear volume and break-up time and a reduction in corneal damage.
Elate Ocular™ is a pro-regenerative allogeneic (not autologous) human platelet derived topical ophthalmic product intended for use in treating the symptoms of chronic dry eye as well as numerous other corneal diseases. This product is formulated from the novel processing of base human platelets sourced from healthy and generally younger eligible donors (versus patients) from U.S. blood collection centers.
Cannabinoids are a class of chemically diverse compounds that are extracted from the cannabis plant. These compounds express their physiological response by binding to specific cannabinoid receptors (CB1 and CB2), which are found throughout the body. The spectrum of available research suggests that some cannabinoids exert multiple effects on the human body, including but not limited to: impacting the immune response, nervous system function and repair, gastrointestinal maintenance and motility, motor function in muscles, pancreatic functionality and blood sugar regulation, and integrity of function in the eye, including the optic nerve. Cannabinoid molecules have been studied widely, and published data point to the potential efficacy of these compounds in treating many disorders or alleviating disease-associated symptoms.
Panag has developed potential new cannabinoid-based therapies for ocular and topical anti-inflammatory and pain markets. The total ocular anti-inflammatory market was estimated at over $3 billion in the USA in 2014 and includes conditions such as post-op inflammation, allergic conjunctivitis and inflammatory dry eye. Panag also developed a cannabinoid topical drug product for the local treatment of pain and inflammation. In 2014, the over the counter sales of topical analgesics were estimated at over $2.5 billion according to IMS. "We will prioritize the development of the ocular therapy as this is a promising innovative product with high medical need and a significant potential financial reward," said Guy Chamberland, Chief Scientific Officer of Tetra Bio-Pharma.