Ocugen, Inc. announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification. OCU410 is a novel, multifunctional modifier gene therapy candidate for geographic atrophy (GA), while OCU410ST targets Stargardt disease. This classification is a crucial step in their European regulatory journey.
The ATMP classification is granted to medicines that offer groundbreaking opportunities for disease treatment and is designed to accelerate the regulatory review timeline. This designation allows Ocugen to engage more frequently with the EMA for scientific advice and protocol assistance. This streamlined process can expedite the potential market authorization for these one-time gene therapies.
OCU410 and OCU410ST represent Ocugen's modifier gene therapy approach, which aims to address complex retinal diseases by regulating multiple pathophysiological pathways. GA affects 2-3 million people in the U.S. and EU, and Stargardt disease affects 100,000 people in the U.S. and Europe. These classifications underscore the recognition of the significant unmet medical needs these therapies aim to address.
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