
Ocugen (NASDAQ:OCGN), a Malvern, Pennsylvania-based clinical-stage biotechnology company developing modifier gene therapies for ophthalmic and other diseases, on Wednesday reported financial results for the fourth quarter and full year ended December 31, 2025, alongside a business update highlighting progress across its three lead modifier gene therapy programs.
The company completed enrollment of 140 patients in the Phase 3 liMeliGhT trial evaluating OCU400, its lead modifier gene therapy candidate for retinitis pigmentosa (RP) associated with mutations in multiple genes including RHO, NR2E3 and CEP290.
Topline data from the study are expected in the first quarter of 2027, with Ocugen planning to initiate a rolling submission of a biologics license application (BLA) to the U.S. Food and Drug Administration in the third quarter of 2026, potentially positioning OCU400 as one of the first gene-agnostic therapies for RP.
In the OCU410 program for geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD), Ocugen reported positive 12-month interim data from the Phase 2 ArMaDa trial.