Ocugen, Inc. announced positive 2-year safety and efficacy data from the Phase 1/2 OCU400 clinical trial for retinitis pigmentosa (RP). The data demonstrated a durable and statistically significant (p=0.01) improvement of a 2-line gain (10 letters on ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes when compared to untreated fellow eyes. This significant improvement was observed in all evaluable subjects, regardless of their specific genetic mutation.
The results validate the gene-agnostic mechanism of action for OCU400, which aims to treat all RP patients with a single, one-time therapy. 100% of treated evaluable subjects showed improvement or preservation of visual function compared to untreated eyes at two years. This long-term data highlights the unique therapeutic potential and durability of OCU400.
The Phase 3 OCU400 liMeliGhT clinical trial is currently ongoing and remains on target for Biologics License Application (BLA) submission in the first half of 2026. This positive 2-year data provides strong support for the continued development of OCU400, which addresses a critical unmet medical need for approximately 2 million RP patients globally.
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