Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the resubmission of a Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a treatment for neovascular age-related macular degeneration, commonly known as wet AMD.

The FDA classified the resubmission as a Class 1 review, with a Prescription Drug User Fee Act target action date of July 29, 2026.

"We are very pleased that the FDA has accepted our resubmitted BLA to review the labelling as part of the final step toward potential approval," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab manufactured in the United States. The company said it has begun pre-launch activities in anticipation of a potential BLA approval. If approved, the company claims it would be the first FDA-approved ophthalmic formulation of bevacizumab.

LYTENAVA™ has previously received Marketing Authorization from the European Commission for European Union member states and from the Medicines and Healthcare products Regulatory Agency in the United Kingdom for the treatment of wet AMD. Outlook Therapeutics has begun commercial launch of the product in Germany, Austria, and the UK.

In the United States, ONS-5010/LYTENAVA™ remains investigational pending FDA approval.