Posted by Michael Wonder on 28 Aug 2025
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD
28 August 2025 - Outlook Therapeutics plans to work with FDA to address the Agency’s issues.
Outlook Therapeutics today announced that the US FDA has issued a complete response letter to its 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.
