Posted by Michael Wonder on 27 May 2026
Outlook Therapeutics wins appeal following formal dispute resolution process for ONS-5010/Lytenava (bevacizumab-vikg) company plans to resubmit BLA to the FDA in June 2026
26 May 2026 - Outlook Therapeutics today announced that the US FDA has granted the appeal following completion of the Formal Dispute Resolution process with the Office of New Drugs.
The FDA concluded that substantial evidence of effectiveness has been established for Lytenava for the treatment of neovascular age-related macular degeneration.
As a result, Outlook Therapeutics expects to resubmit the ONS-5010/Lytenava (bevacizumab-vikg) biologics license application in June 2026.
