Ocugen has dosed the first patient in the global phase III ArMaDa3 study evaluating its modifier gene therapy candidate OCU410 for geographic atrophy secondary to dry age-related macular degeneration. The study follows a Type B End-of-phase II meeting with the FDA in July 2026, which aligned on key design elements including endpoints, dose, and a single pivotal study pathway to support a biologics license application. This randomized registrational study, the first pivotal gene therapy study in GA, will enroll 237 patients randomized 2:1 to receive a single subretinal injection of OCU410 at 5×10^10 vg/mL or remain untreated. The primary endpoint measures the rate of change in square root-transformed GA lesion area through month 12, with secondary endpoints evaluating functional vision. Ocugen expects to file a BLA for OCU410 in 2028 and is in discussions with the European Medicines Agency for potential alignment.
Ocugen IncDosed first patient in Phase III gene therapy study for geographic atrophy, a key milestone.
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