Ocugen registers Phase 3 trial of OCU410 gene therapy for geographic atrophy in dry AMD

Ocugen's week centered on the registration of a new registrational trial for its gene therapy candidate OCU410.

• Phase 3 study (NCT07770828, "OCU410-301"): a multicenter, randomized, controlled trial testing a single subretinal injection of OCU410 against an untreated control arm in patients with geographic atrophy secondary to dry AMD. Subjects will be randomized in a 2:1 ratio to treatment or control, with 237 total subjects planned across the treatment arm (N=158) receiving OCU410 and a control arm (N=79).¹ The primary outcome is the rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12¹. The record's overall status is recruiting, with one of three U.S. sites, Valley Retina Institute in McAllen, Texas, listed as recruiting while the other two, in Phoenix, Arizona and Erie, Pennsylvania, are not yet recruiting.¹