OCU410 - (ArMaDa)

November 4, 2026: Ocugen (NASDAQ: OCGN) reported Q3 2026 updates across three late-stage gene therapy programs for blindness diseases. OCU400 for retinitis pigmentosa received Provisional Approval and Priority Designation from The Bahamas’ LARTA Board; Ocugen signed with Global Alliance for Regenerative Medicine to manage patient care, is preparing the site, and said final approval and potential enrollment could begin by year-end. OCU400 also was licensed in MENA to Roots Pharmaceutical, with terms including up to $4 million in upfront and initial development milestones, up to $255 million in sales milestones, and a 22% royalty; Ocugen will manufacture commercial supply. Phase 3 liMeliGhT topline data (140 patients) are expected in Q1 2027, followed by a planned BLA submission.

OCU410ST for Stargardt disease: Phase 2/3 pivotal confirmatory trial topline data (n=63) are expected in Q2 2027, with a planned BLA to follow.

OCU410 for geographic atrophy: the first patient was dosed in the 240-subject global Phase 3 ArMaDa3 trial; patients are randomized 2:1 to a single subretinal injection of OCU410 or untreated control, with GA lesion growth over 12 months as the primary endpoint. The company also said 12-month Phase 2 ArMaDa2 results were presented at three scientific conferences, including two podium presentations at AAO 2026.

Cash, cash equivalents, restricted cash, and short-term investments were $84.6 million as of September 30, 2026, with runway expected into 2028.