FDA Accepts Resubmitted BLA for ONS-5010 in Wet AMD, Decision Due This Month
ByAinvest
Friday, Nov 14, 2025 3:36 am ET1min read
OTLK--
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.
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