Outlook Therapeutics resubmits bevacizumab-vikg BLA to FDA for nAMD treatment

Outlook Therapeutics resubmitted its Biologics License Application for ONS-5010/LYTENAVA to the FDA after successfully appealing a Complete Response Letter, with a Class 1 review designation and expected decision within 60 days. If approved, the product would be the first FDA-approved ophthalmic formulation of bevacizumab, potentially creating a significant market opportunity in the wet AMD treatment space.