FDA Issues Complete Response Letter To Outlook Therapeutics' ONS-5010/LYTENAVA BLA For Wet AMD; FDA Has Again Recommended That Confirmatory Evidence Of Efficacy Be Submitted To Support The Application, However The FDA Has Not Indicated What Type Of Confirmatory Evidence Would Be Acceptable

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 that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the ONS-5010/LYTENAVA™ (bevacizumab-vikg) biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD).

In the CRL, the FDA noted that the additional mechanistic and natural history data information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application, however the FDA has not indicated what type of confirmatory evidence would be acceptable.