Lytenava (bevacizumab-vikg; Outlook Therapeutics) moved a step closer to potential approval for neovascular age-related macular degeneration (nAMD) after the US Food and Drug Administration (FDA) granted the company’s appeal following completion of a Formal Dispute Resolution (FDR) process with the Office of New Drugs (OND). According to the company, the FDA concluded that substantial evidence of effectiveness has been established for Lytenava in the treatment of nAMD.

The decision follows a December 30, 2025, complete response letter issued for the biologics license application (BLA) for ONS-5010/Lytenava. Outlook Therapeutics subsequently entered the FDR process after a recent Type A meeting with the FDA’s Division of Ophthalmology and Office of Specialty Medicine.

In its formal response, OND stated that results from the NORSE TWO trial, together with confirmatory evidence from NORSE EIGHT, natural history data, and mechanistic and pharmacodynamic findings, established substantial evidence of effectiveness for Lytenava in nAMD.

The response directs the FDA's division of ophthalmology and office of specialty medicine to work with Outlook Therapeutics to reach an agreement on final labeling. Outlook said it expects to resubmit the BLA in June 2026. As indicated in the formal decision, it is anticipated that this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission, the company said in a press release. 

If approved, ONS-5010/Lytenava would be the first FDA-approved ophthalmic formulation of bevacizumab supported by an FDA-approved manufacturing process, FDA-approved labeling, as well as pharmacovigilance, the company said.