Ocugen, Inc. is a biopharmaceutical company in the clinical development phase, primarily dedicated to pioneering gene therapies aimed at treating various ophthalmic conditions leading to blindness. The company's developmental pipeline features several key candidates: OCU400: An innovative gene therapy designed to reinstate both the function and structural integrity of the retina across a broad spectrum of genetically diverse inherited retinal diseases, such as retinitis pigmentosa and Leber congenital amaurosis. OCU410: Another gene therapy candidate, currently being developed to address dry age-related macular degeneration (AMD). OCU200: A novel fusion protein, presently undergoing preclinical evaluation for its potential in treating diabetic macular edema, diabetic retinopathy, and wet AMD. Ocugen maintains significant strategic collaborations, including a partnership with CanSino Biologics Inc. for the joint development and manufacturing of gene therapies, and an alliance with Bharat Biotech for the commercialization of COVAXIN within the United States market. The company's corporate headquarters are situated in Malvern, Pennsylvania.
Ocugen Announces First Patient Dosed in Phase 3 Registrational Trial of OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Ocugen dosed the first patient in the global Phase 3 registrational trial of OCU410, a modifier gene therapy for geographic atrophy secondary to dry age-related macular degeneration.
The trial design is fully aligned with the FDA, which recently granted RMAT designation to support an accelerated approval pathway and a potential BLA filing in 2028.
Phase 2 data supporting the trial showed a 31% reduction in lesion growth rate compared to control, with no serious adverse events reported.