FX.co ★ Outlook Therapeutics Receives Positive CHMP Opinion For ONS-5010 To Treat Wet AMD

Outlook Therapeutics, Inc. revealed on Friday that its new ophthalmic formulation of Bevacizumab—known as ONS-5010/Lytenava or 'Bevacizumab gamma'—had been positively recieved by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). This formulation was developed specifically to manage wet age-related macular degeneration (wet AMD) within the European Union. The CHMP’s approval was based on the results yielded from Outlook Therapeutics' clinical program for ONS-5010, comprised of three successful registration clinical trials for wet AMD. If approved, ONS-5010 is expected to earn a decade of market exclusivity within the European Union. The company has also indicated that it is considering launching direct sales or forming partnerships within Europe. A verdict from the European Commission is expected approximately 67 days following the CHMP's positive opinion.