FX.co ★ Ocugen Receives Orphan Medicinal Product Designation From EMA For OCU410ST

Ocugen, Inc. (OCGN) has announced that the European Medicines Agency has awarded orphan medicinal product status to OCU410ST for the treatment of ABCA4-associated retinopathies. These include Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3. Previously, in April 2023, the FDA had granted orphan drug designation to OCU410ST.

Dr. Huma Qamar, Chief Medical Officer at Ocugen, commented: "These significant clinical and regulatory advancements bolster the potential of OCU410ST as a groundbreaking single-dose therapy for inherited retinal diseases."

Ocugen intends to seek an accelerated marketing authorization for OCU410ST.