Ocugen, Inc. today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of its OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD). Key findings from the low dose cohort at six months showed no drug-related serious adverse events. This indicates a favorable safety profile for the novel modifier gene therapy.
The data revealed considerably slower lesion growth of 21.4% from baseline in treated eyes compared to untreated fellow eyes, which followed the natural history of the disease. OCU410 treatment also demonstrated increasing preservation of retinal tissue around GA lesions over six months. Furthermore, 100% of the OCU410 treated eyes showed stabilization of visual function, as measured by low luminance visual acuity (LLVA).
OCU410 is designed to address multiple aspects of GA beyond the complement pathway, which is the focus of currently approved treatments. With approximately three million people living with GA in the U.S. and Europe combined, and limited treatment options, these preliminary results highlight OCU410's potential as a one-time treatment. The data affirms the potential for modifier gene therapy to address blindness diseases affecting millions.
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