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Ocugen announces preliminary efficacy, safety data from Phase 1/2 OCU410 trial
The Fly

Ocugen announces preliminary efficacy, safety data from Phase 1/2 OCU410 trial

Ocugen (OCGN) announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy, GA, secondary to dry age-related macular degeneration, dAMD. Key findings include: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and-most importantly-there was a positive effect on the functional visual measure of low luminance visual acuity, LLVA. The OCU410 Phase 1 trial is evaluating nine patients in three dose cohorts. The following data was observed for the three patients in the low dose cohort at six months: Considerably slower lesion growth from baseline in treated vs. untreated fellow eyes that followed the natural history of the disease. This result is favorable when compared to published data on pegcetacoplan injected every month or every other month over six months. OCU410 treatment showed increasing preservation of retinal tissue around the GA lesions of treated eyes over six months, which also compared favorably to published data on pegcetacoplan given monthly and every other month. 100% of the OCU410 treated eyes showed stabilization of visual function demonstrating treatment benefit as measured by LLVA.

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