Ocugen, Inc., a biopharmaceutical company, develops treatments for sight threatening diseases. The company offers drugs for ocular graft versus host disease, retinitis pigmentosa, geographic atrophy, wet age-related macular degeneration, and diabetic retinopathy diseases. Its pipeline includes OCU100, a recombinant form of lens epithelium derived growth factor for the treatment of retinitis pigmentosa; OCU200, an anti-angiogenic tumstatin fusion protein for the treatment of wet age-related macular degeneration; OCU300, a repurposed drug for ocular applications; and OCU310 (brimonidine/steroid combination therapy), a topical formulation for the treatment of dry eye disease. The company was fo...
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Malvern, PA 19355
Founded in 2013
Ocugen, Inc. Reports Positive Phase 2 Clinical Results Demonstrating Proof-Of-Concept for its Novel Combination Therapy for Dry Eye Disease
Mar 20 18
Ocugen, Inc. announced positive results from its Phase 2 proof-of-concept clinical trial of OCU310, a novel combination of brimondine tartrate and a corticosteroid, loteprednol etabonate, being developed as a treatment for dry eye disease. The randomized, multi-center, double-blinded, placebo-controlled study met its primary endpoint of tolerability over a 12-week period. The study results also showed meaningful improvements across a number of endpoints related to the signs and symptoms of dry eye disease when compared to placebo. Based on these encouraging results, Ocugen remains on track to advance OCU310 into Phase 3 clinical studies in the third quarter 2018. OCU310 is a unique ophthalmic nanoemulsion/suspension product being developed as a treatment for dry eye disease. It contains a proprietary nanoemulsion of brimonidine tartrate (0.2%), an FDA-approved ophthalmic drug with unique anti-inflammatory, immunosuppressive, vasoconstrictive and analgesic properties, combined with a low dose of loteprednol etabonate (0.2%), an FDA approved corticosteroid for ophthalmic use. The fact that both active components of the OCU310 combination product are approved by FDA for ophthalmic use, significantly derisks OCU310 from a product safety and regulatory (505(b)(2) pathway) standpoint. These active components, which have complementary mechanisms of action, could result in an enhanced product profile compared to currently marketed products for dry eye. OCU310 is expected to have a more rapid onset of action, improved tolerability and more potent relief from dry eye signs and symptoms due to its novel nanoemulsion formulation of brimondine combined with loteprednol. In this Phase 2, randomized, multicenter, placebo-controlled, double-blinded study, patients with dry eye disease received 0.2% brimonidine tartrate alone or with 0.2% loteprednol etabonate (OCU310) or placebo. Patients were treated with eye drops twice daily (BID) for a period of 12 weeks. All patients were assessed for tolerability using a visual analog scale (VAS), and the results showed that tolerability was similar for patients receiving OCU310 or placebo at all post-baseline visits through week 12, fulfilling the study's primary endpoint. In addition, overall adverse event rates were low and similar to placebo, supporting the safety and tolerability of OCU310. The study was not powered to show statistical significance for efficacy, but prespecified exploratory efficacy endpoints to assess changes in key signs and symptoms of dry eye disease were evaluated. Of the symptom endpoints, the Symptom Assessment Questionnaire in Dry Eye (SANDE), which measured the frequency and severity of eye dryness/irritation, was the most relevant. SANDE scores improved from baseline at all subsequent time points, with consistently greater reductions in SANDE score for the OCU310 group compared to patients who received placebo, indicating a greater degree of relief from dry eye discomfort. As for sign endpoints, conjunctival staining with lissamine green (only measured at 12-week time point) showed a greater reduction from baseline staining for patients receiving OCU310 compared to the placebo group. Results were similar for corneal lissamine green staining, indicating greater improvement over placebo in a key sign of dry eye disease.
Ocugen, Inc. Presents at Oppenheimer 28th Annual Healthcare Conference, Mar-20-2018 10:00 AM
Mar 15 18
Ocugen, Inc. Presents at Oppenheimer 28th Annual Healthcare Conference, Mar-20-2018 10:00 AM. Venue: Westin New York Grand Central Hotel, New York, New York, United States. Speakers: Shankar Musunuri, Founder, Chairman & CEO.
Ocugen, Inc. Expands Focus on Inherited Retinal Disorders by Licensing Novel Modifier Gene Therapy Platform
Dec 20 17
Ocugen, Inc. announced a strategic expansion to its leading ophthalmology product development pipeline that enhances the company's focus on inherited retinal disorders (IRDs). Ocugen has obtained an exclusive worldwide license to develop and commercialize future ophthalmology products based on technology from the Schepens Eye Research Institute of Massachusetts Eye and Ear. The novel modifier gene therapy platform has the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs and other degenerative retinal diseases, leading to multiple potential product opportunities.