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.