Outlook Therapeutics announces acceptance of BLA for ONS-5010

Outlook Therapeutics (OTLK) announced that the U.S. Food and Drug Administration, FDA, has acknowledged receipt of the resubmission of the Biologics License Application, BLA, for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. The FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 27, 2025 action letter, which results in a 60 day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act, PDUFA, goal date of December 31, 2025. ONS-5010, if approved, will be branded as LYTENAVA for the treatment of wet AMD.