Ocugen, Inc. (OCGN) Monday said that the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) has provided a positive opinion for Advanced Therapy Medicinal Product (ATMP) classification for the company's gene therapy candidate OCU400 to treat Retinitis pigmentosa.
A phase 3 study of OCU400 in Retinitis pigmentosa (RP), a genetic disease that causes gradual vision loss, is underway.
"Underscoring the vital need for gene-agnostic treatments for diseases with multiple mutations such as RP, both the U.S. Food and Drug Administration (FDA) and EMA have acknowledged that the ongoing single, pivotal Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA)/MAA submissions," the company said in a statement.
Upon completion of the Phase 3 study, Ocugen plans to file simultaneously in the U.S. and Europe .
For comments and feedback: editorial@rttnews.com