FX.co ★ Ocugen Gets Positive Opinion For OCU400 Advanced Therapy Medicinal Product Classification

Ocugen, Inc. (OCGN) announced on Monday that the European Medicines Agency's Committee for Advanced Therapies (CAT) has issued a favorable opinion regarding the classification of OCU400, their gene therapy candidate, as an Advanced Therapy Medicinal Product (ATMP) for the treatment of Retinitis Pigmentosa.

The company is currently conducting a Phase 3 clinical trial for OCU400, aimed at addressing Retinitis Pigmentosa (RP), a hereditary disease that leads to progressive vision deterioration.

Highlighting the critical need for gene-agnostic therapies to address conditions with diverse mutations like RP, Ocugen stated, "Both the U.S. Food and Drug Administration (FDA) and the EMA have recognized that the ongoing, pivotal Phase 3 trial of OCU400 could suffice for submissions of Biologics License Application (BLA) and Marketing Authorization Application (MAA)."

Following the completion of the Phase 3 trial, Ocugen intends to proceed with filing applications concurrently in both the U.S. and Europe.