MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatr ...

Conference Call and Webcast Today at 8:30 a.m. ET OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) is progressing well and on target for potential BLA/MAA filings by mid-2026Anticipate initiating OCU410ST Phase 2/3 pivotal confirmatory clinical trial for Stargardt disease mid- 2025 MALVERN, Pa., May 09, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2025 financia ...

Core Insights - Ocugen, Inc. is set to present its innovative modifier gene therapy platform at two major conferences, highlighting its ongoing clinical trials for retinal diseases [1][2] - The company aims to file three Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs) within the next three years, addressing significant unmet medical needs [2] Conference Participation - Ocugen will participate in the ARVO 2025 Annual Meeting and Retina World Congress, showcasing its research and engaging with the retina community [1][2] - The company will present on its clinical trials for OCU400, OCU410ST, and OCU410, focusing on retinitis pigmentosa, Stargardt disease, and geographic atrophy respectively [1][5][6] Clinical Trials - OCU400 is currently in a Phase 3 clinical trial (LiMeliGhT) for retinitis pigmentosa, while OCU410ST is in a Phase 2/3 pivotal confirmatory trial for Stargardt disease [1][5] - OCU410 is undergoing a Phase 2 clinical trial (ArMaDa) for geographic atrophy secondary to dry age-related macular degeneration [1][6] Company Vision - Ocugen is committed to developing therapies for inherited retinal diseases and aims to provide access to these treatments globally [8][9] - The company emphasizes its gene-agnostic approach, which has the potential to treat multiple retinal diseases with a single product [2][9]