(RTTNews) - Ocugen, Inc. (OCGN) announced the European Medicines Agency has granted orphan medicinal product designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3. The FDA previously granted orphan drug designation to OCU410ST in April 2023.
Huma Qamar, Chief Medical Officer at Ocugen, said: "These positive clinical and regulatory milestones continue to support the potential for OCU410ST to address inherited retinal diseases with a one-time therapy for life."
Ocugen plans to pursue an accelerated marketing authorization application for OCU410ST.
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