Ocugen said enrollment is complete in its Phase 3 liMeliGhT registrational trial of OCU400, a modifier gene therapy for broad retinitis pigmentosa. The one-year study enrolled 140 patients randomized 2:1 to treatment (2.5×10 vg per eye, 250 µL) or untreated control across an RHO arm and a gene-agnostic arm, including patients aged 3 years and older; the primary endpoint is 12-month change in visual function measured by luminance dependent navigation assessment (LDNA) based on Lux Level improvement. The company expects topline Phase 3 data in 1Q 2027 and said it remains on track to file a rolling Biologics License Application in 3Q 2026, with potential approval in 2027; it also noted the EMA has found the U.S.-based trial acceptable for a future Marketing Authorization Application submission. Ocugen also reported updated long-term Phase 1/2 results at three years, stating 88% (7/8) of evaluable treated subjects showed improvement or preservation versus untreated fellow eyes and an approximately 2-line low-luminance visual acuity gain (N=8) across multiple mutation types, with no new treatment-related serious adverse events reported.

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