FDA Accepts Resubmitted BLA for ONS-5010 in Wet AMD, Decision Due This Month

Outlook Therapeutics' shares rose 15% after the FDA accepted the resubmitted Biologics License Application for ONS-5010, a treatment for wet age-related macular degeneration. ONS-5010, branded as LYTENAVA, is a recombinant humanized monoclonal antibody that blocks VEGF activity. The FDA has assigned a decision date of December 31, 2025. If approved, it will be the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD.