Posted by Michael Wonder on 01 Jan 2026
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD (December 2025)
31 December 2025 - FDA issues complete response letter for resubmitted ONS-5010 BLA.
Outlook Therapeutics today announced that the US FDA has issued a complete response letter to the ONS-5010/Lytenava (bevacizumab-vikg) biologics license application resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration.
