Posted by Michael Wonder on 30 Aug 2023
Outlook Therapeutics provides regulatory update on FDA review of ONS-5010 / Lytenava (bevacizumab-vikg) for the treatment of wet AMD
30 August 2023 - FDA issues complete response letter for ONS-5010 biologics license application based on CMC and need for further confirmatory clinical evidence.
Outlook Therapeutics today announced the US FDA has issued a complete response letter to the Company’s biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
