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Ocugen, Inc. Announces Dosing Completion in the Phase 2 ArMaDa Clinical Trial for OCU410—a Multifunctional Modifier Gene Therapy for the Treatment of Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
OCGNOcugen(OCGN) Newsfilter·2025-02-12 12:42

Core Viewpoint - Ocugen, Inc. has completed dosing ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410, a novel gene therapy for geographic atrophy (GA), which is a severe form of dry age-related macular degeneration (dAMD) [1][3] Company Summary - Ocugen is a biotechnology company focused on developing gene and cell therapies, biologics, and vaccines [10] - The company aims to address significant unmet medical needs in the field of ophthalmology, particularly for conditions like dAMD and GA [10] Clinical Trial Details - The ArMaDa clinical trial is assessing the safety and efficacy of OCU410, with 51 patients randomized into treatment and control groups [4][7] - OCU410 is designed as a one-time treatment, potentially reducing the burden of frequent injections required by current therapies [4][5] - The trial has shown promising preliminary results, including a 44% slower lesion growth in treated eyes compared to untreated eyes at 9 months [5] Disease Context - dAMD affects approximately 10 million Americans and over 266 million people globally, with GA impacting around 2-3 million people in the U.S. and Europe [1][8] - Current treatment options for dAMD are limited and often involve frequent injections with significant side effects [2][4] OCU410 Mechanism - OCU410 utilizes an adeno-associated virus (AAV) platform to deliver the RORA gene, targeting multiple pathways associated with dAMD pathophysiology [9] - The therapy aims to improve lipid metabolism, reduce oxidative stress, and inhibit inflammation, offering a multifaceted approach to treatment [9]