MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company, recently made a significant stride in its quest for innovative vision restoration solutions. The company announced that the first patient has been dosed in the ArMaDa Phase 1/2 clinical trial of OCU410 (AAV-RORA), a groundbreaking modifier gene therapy product candidate being developed to treat dry age-related macular degeneration (dAMD).
OCU410, which is designed to target multiple pathways causing dAMD, including lipid metabolism, inflammation, oxidative stress, and complement activation, marks a crucial advancement in the treatment of dAMD. “OCU410 addresses gaps among other therapies available and in development for dAMD as a potential one-time treatment for life,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
The Phase 1/2 trial aims to evaluate the safety and efficacy of OCU410 in treating geographic atrophy (GA), a condition secondary to dAMD. The study will be conducted in two phases. Phase 1 involves a multicenter, open-label, dose-ranging study, while Phase 2 comprises a randomized expansion phase where subjects will be assigned randomly to either one of two OCU410 dose groups or an untreated control group.
OCU410 is a potential curative therapy delivered via a single sub-retinal injection. Unlike other available therapeutic options that target only complement activation and require approximately 6-12 intravitreal injections annually, OCU410 offers a more comprehensive solution.
Dr. Arun Upadhyay, Chief Scientific Officer and Head of R&D at Ocugen, expressed his enthusiasm about the progress. “OCU410 offers hope for those battling GA that are faced with limited treatment options and the real prospect of ultimately losing their vision.”
The first surgery, performed at Associated Retina Consultants (ARC) in Phoenix, AZ, successfully delivered the new gene underneath the retina, the light-sensitive nerve tissue lining the inside of the eye. Dr. Benjamin Bakall, director of clinical research at ARC and clinical assistant professor at University of Arizona, College of Medicine – Phoenix, emphasized the need for novel durable and effective treatments for GA, one of the most common causes of vision loss globally.
The successful commencement of this trial represents a significant milestone in Ocugen’s mission to restore vision and marks an exciting development in the field of ophthalmic gene therapy.
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