Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today provided an update following its recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg).

The Company expects to continue engaging in discussions with the FDA to further clarify the Agency's views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010/LYTENAVA™ toward potential U.S. approval.