GlobeNewswire·Nov 13, 2025, 8:30 AM ET

Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

Outlook Therapeutics announced FDA acknowledgment of the resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg).
The FDA classified the resubmission as a complete Class 1 response to the August 27, 2025 action letter, initiating a 60-day review period.
The Prescription Drug User Fee Act (PDUFA) goal date for the application is set for December 31, 2025.
If approved in the U.S., ONS-5010 will be branded as LYTENAVA™ for the treatment of wet age-related macular degeneration (wet AMD).
LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive Marketing Authorization from the European Commission and the UK MHRA.
In the U.S., the product remains investigational; approval would make it the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications.
ONS-5010 is a recombinant humanized monoclonal antibody that neutralizes VEGF activity to reduce vascular leakage and new blood vessel formation in the retina.
Outlook Therapeutics has already commenced commercial launch of the product in Germany and the UK.