Ocugen (OCGN) said Monday that the European Medicines Agency's Committee for Advanced Therapies had issued a positive opinion for OCU400's classification as advanced therapy medicinal product.
OCU400, Ocugen's gene therapy candidate to treat retinitis pigmentosa, is being evaluated in an ongoing phase 3 trial, the company said.
Ocugen said it intends to file an application for marketing authorization in the EU next year.
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