FDA accepts resubmitted BLA for Outlook's LYTENAVA with July 29, 2026 decision date

Outlook Therapeutics announced FDA acceptance of its resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for wet AMD, with a PDUFA target action date of July 29, 2026. If approved, LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab with standardized manufacturing and FDA-approved labeling.