LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NORSE EIGHT)

June 16, 2026: Outlook Therapeutics, Inc. (NASDAQ: OTLK) said the FDA acknowledged receipt of its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg) for neovascular age-related macular degeneration (wet AMD). The FDA classified the resubmission as a Class 1 review and set a PDUFA target action date of July 29, 2026. The company said it has initiated pre-launch activities in anticipation of a pending U.S. approval.

The release also notes LYTENAVA (bevacizumab gamma) has Marketing Authorization in the EU via the European Commission and in the UK via the MHRA for wet AMD, and that commercialization has commenced in Germany, Austria, and the UK (with EU pricing/reimbursement approvals needed in certain member states).