Outlook Therapeutics announces acceptance of BLA by U.S. FDA 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 AMD. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act, PDUFA, goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity.