Outlook Therapeutics, Inc., a biopharmaceutical company focused on enhancing the standard in the treatment of retina diseases, 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 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).
The FDA has advised that it considers the BLA resubmission a complete Class 1 response to the Aug. 27, action letter, resulting 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 Dec. 31.
If approved, it will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet AMD.
“We are pleased that the FDA has accepted our resubmission of the BLA for ONS-5010, marking another important milestone in our effort to bring the first and only FDA-approved ophthalmic formulation of bevacizumab to patients in the United States suffering from wet AMD,” said Bob Jahr, chief executive officer of Outlook Therapeutics.
“Our team has worked diligently to address the feedback from the agency, strengthen the resubmitted BLA and resolve the outstanding issue highlighted in the complete response letter from August 2025.”
