GlobeNewswire·Jun 16, 2026, 8:02 AM ET

Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD

Outlook Therapeutics announced that the FDA acknowledged receipt of its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for treating neovascular age-related macular degeneration.
The FDA classified the resubmission as a Class 1 review with a PDUFA target action date of July 29, 2026.
Upon approval, ONS-5010/LYTENAVA™ will become the first FDA-approved ophthalmic formulation of bevacizumab featuring standardized manufacturing, approved labeling, and robust pharmacovigilance.
The company has initiated pre-launch activities in the U.S. while awaiting pending BLA approval.
LYTENAVA™ is already approved by the European Commission for the EU & by the UK's MHRA for wet AMD, with commercial launches having commenced in Germany, Austria, & the UK.
ONS-5010/LYTENAVA™ is a recombinant humanized monoclonal antibody that neutralizes VEGF to reduce retinal vascular leakage & new blood vessel formation.
Outlook Therapeutics is the developer focused on commercializing ONS-5010/LYTENAVA™, which represents the first ophthalmic bevacizumab formulation to receive European & UK marketing authorization.