Ocugen’s OCU400 granted positive opinion by EMA in retinitis pigmentosa

Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee for Advanced Therapies for OCU400 Advanced Therapy Medicinal Product classification. OCU400 is the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa indication. ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance as the company pursues Marketing Authorization Application filing in 2026. Both the FDA and EMA have acknowledged that the ongoing single, pivotal Phase 3 trial of OCU400 can suffice for Biologics License Application/MAA submissions. Ocugen intends to file simultaneously in the U.S. and Europe upon completion of the Phase 3 trial. The Phase 3 OCU400 liMeliGhT clinical trial is currently enrolling.