Ocugen Announces Topline 12-month Data from Phase 2 ArMaDa Clinical Trial Evaluating OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
View original at globenewswire.comOcugen Announces Topline 12-month Data from Phase 2 ArMaDa Clinical Trial Evaluating OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration Optimal dose intended for Phase 3 demonstrates statistically significant reduction in lesion growth (31%) versus control at 12 months…
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OCU410 medium dose group showed 27% slower rate of ellipsoid zone (EZ) loss compared to control, indicating structural preservation of photoreceptors
60% confidencePhase 2 data consistently demonstrates statistically significant reduction of GA lesion growth after treatment with OCU410 optimal dose, benchmarked against natural history data
60% confidenceOCU410 moves Ocugen one step closer to bringing a transformative one-time treatment to GA patients globally
60% confidenceAnticipated Phase 3 pivotal confirmatory trial will include up to 300 subjects with adaptive design powered at over 95%
60% confidenceNo serious adverse events and no adverse events of special interest related to OCU410 reported to date
60% confidenceSubgroup analysis showed 33% reduction in lesion growth compared to control in medium dose OCU410 for subjects with baseline GA lesions ≥5 mm2 and ≤17.5 mm2
60% confidenceCurrent GA therapies require 6-12 injections per year indefinitely, leading to substantial burden and significant dropout rates in real-world practice
60% confidenceOCU410 shows potential 2X treatment benefit compared to currently approved therapies which report 15% and 22% reductions at 12 and 24 months respectively
60% confidenceNo OCU410-related serious adverse events observed and no cases of endophthalmitis, retinal detachment, vasculitis, choroidal neovascularization, or ischemic optic neuropathy reported to date
60% confidenceOCU410 has the potential to eliminate chronic treatment burden associated with monthly or every-other-month intravitreal injections and reduce treatment attrition
60% confidencePhase 2 trial confirmed robust treatment effect from a well-controlled trial, enabling Phase 3 progression with high confidence
60% confidenceOptimal dose (medium) of OCU410 demonstrates statistically significant 31% reduction in lesion growth versus control at 12 months (p<0.05)
60% confidence55% of treated patients demonstrated ≥30% lesion size reduction versus control
60% confidence