The FDA issued a complete response letter noting its rejection of the biologics license application for ONS-5010 for the treatment of wet age-related macular degeneration, according to a press release from Outlook Therapeutics.
The FDA did not approve the biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg) due to “several CMC [chemistry, manufacturing and controls] issues, open observations from pre-approval manufacturing inspections and a lack of substantial evidence,” Outlook Therapeutics said in the release, despite the phase 3 NORSE TWO clinical trial