FDA grants appeal for Outlook's LYTENAVA bevacizumab; BLA resubmission planned June 2026

The FDA's Office of New Drugs determined that substantial evidence supports the effectiveness of ONS-5010/LYTENAVA for neovascular age-related macular degeneration following the formal dispute resolution process. Outlook plans to resubmit the biologics license application in June 2026 with an expected FDA decision within 60 days, potentially clearing a path to approval for the first FDA-approved ophthalmic bevacizumab formulation.