Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.

When approved, ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. Outlook Therapeutics has initiated pre-launch activities in anticipation of the pending BLA approval.