Ocugen获得欧盟对OCU 400 ATMP分类的积极评价

Ocugen (NASDAQ:OCGN) said it has received a positive opinion from European Medicines Agency regulators for Advanced Therapy Medicinal Product classification for its gene therapy OCU400 in the treatment of retinitis pigmentosa. 

Ocugen (NASDAQ:OCGN) said the ATMP classification will accelerate the regulatory review timeline for the product. It will also allow the company to interact with the EMA more frequently for scientific advice and protocol assistance as it advances towards filing a market authorization application. Ocugen (OCGN) hopes to file an application in 2026.

The company said both the FDA and EMA have agreed that one pivotal Phase 3 study could be used to support market applications for the therapy. It plans to file the applications simultaneously once the Phase 3 study is completed, according to a statement.