Outlook Therapeutics Wins FDA Appeal for LYTENAVA™ BLA; Resubmission Expected June 2026

On May 26, 2026, Outlook Therapeutics announced that the FDA granted its appeal following a Formal Dispute Resolution (FDR) process regarding the December 2025 Complete Response Letter (CRL) for LYTENAVA™ (bevacizumab-vikg). The FDA's Office of New Drugs (OND) concluded that substantial evidence of effectiveness has been established for LYTENAVA™ in treating neovascular age-related macular degeneration (nAMD), based on results from the NORSE TWO trial along with confirmatory data from NORSE EIGHT and other supportive studies. The FDA has directed the Division of Ophthalmology to work with the company on final labeling. Outlook Therapeutics plans to resubmit its Biologics License Application (BLA) in June 2026 as a Class 1 resubmission. Under this classification, a PDUFA action date and decision are expected within 60 days of the FDA’s receipt of the resubmission. If approved, LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications.