Outlook Therapeutics Resubmits BLA for ONS-5010/LYTENAVA to FDA

Outlook Therapeutics, Inc. announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration (nAMD). This follows a successful appeal of a December 2026 Complete Response Letter, with the FDA Office of New Drugs concluding that substantial evidence of effectiveness has been established and no additional trials are required. The resubmission is designated as a Class 1 review, with a PDUFA date and decision expected within 60 days of FDA's receipt. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab.