Ocugen Announces Positive Preliminary Phase 2 Data from OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Core Insights - Ocugen, Inc. announced positive preliminary 12-month data from the Phase 2 ArMaDa clinical trial for OCU410, a gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD) [1][4] - The global prevalence of dAMD is 266 million, with GA affecting approximately 2-3 million people in the U.S. and Europe [1][8] Clinical Trial Findings - Phase 2 results show a 46% reduction in lesion growth compared to control, with a 50% responder rate achieving over 50% lesion size reduction [5][6] - No serious adverse events related to OCU410 were reported in both Phase 1 and Phase 2 trials [2][5] - The medium dose achieved a 54% lesion reduction, while the high dose achieved a 36% reduction compared to control [6] Treatment Landscape - Current treatment options for dAMD in the U.S. are limited and involve frequent injections with side effects, leaving approximately 2 million patients in Europe without approved treatments [2][8] - OCU410 is a multifunctional gene therapy targeting multiple pathways associated with GA, contrasting with existing therapies that target a single mechanism [3][9] Future Developments - Ocugen plans to file a Biologics License Application (BLA) for OCU410 in 2028, aiming for three regulatory submissions for marketing authorization within three years [7][10] - Full data from the Phase 2 clinical trial is expected to be reported later this quarter, with Phase 3 trials anticipated to begin in 2026 [4][7]