Outlook Therapeutics Inc. (OTLK), a clinical-stage biopharmaceutical company, announced on Monday the resubmission of a biologics license application (BLA) for LYTENAVA, a treatment for age related macular degeneration, to the U.S. Food and Drug Administration (FDA).
LYTENAVA/ONS-5010 (bevacizumab-vika) is an investigational, humanized monoclonal antibody developed to bind with the human vascular endothelial growth factor (VEGF) to prevent endothelial cell proliferation in neovascular age-related macular degeneration. It has received approval for marketing in the EU and UK.
The company previously successfully appealed the December 2025 complete response letter (CRL) related to the BLA reviewed by the FDA. In their decision, the FDA Office of New Drugs concluded that evidence of effectiveness had been established for LYTENAVA, and further trials were not required. The FDA's Division of Ophthalmology and Office of Specialty Medicine then worked with Outlook to achieve alignment on final product labelling.
The application will be considered Class I resubmission, with a PDUFA date and decision expected within 60 days of FDA's receipt of the resubmission.
OTLK is currently trading at $0.78, up 7.97%.
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