Outlook Therapeutics Submits Formal Dispute Resolution Request to FDA for LYTENAVA BLA

On April 7, 2026, Outlook Therapeutics announced that it has submitted a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration (FDA). This request is a follow-up to a Type A meeting held on March 2, 2026, regarding the Complete Response Letter (CRL) issued by the FDA on December 30, 2025, for the Biologics License Application (BLA) of ONS-5010/LYTENAVA™ (bevacizumab-vikg). The drug is intended for the treatment of neovascular age-related macular degeneration (wet AMD). The FDA has accepted the FDRR and granted a meeting with the deciding official, scheduled to take place in April 2026. Outlook Therapeutics maintains that clinical data from the NORSE TWO and NORSE EIGHT trials provide sufficient evidence of safety and efficacy to support approval. While LYTENAVA™ has already received marketing authorization in the EU and UK, it remains investigational in the United States. The company aims for ONS-5010 to become the first FDA-approved ophthalmic formulation of bevacizumab.