Outlook Therapeutics Inc. (NASDAQ: OTLK) announced it has resubmitted its Biologics License Application to the U.S. Food and Drug Administration for ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat neovascular age-related macular degeneration.

The resubmission follows a successful appeal of a Complete Response Letter the FDA issued in December 2026. The FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA™ and that additional trials are not required.

The FDA directed its Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics on final product labeling. The resubmission received a Class 1 review designation with a PDUFA date and decision expected within 60 days of FDA receipt.

"We are incredibly pleased to reach this important milestone," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "This resubmission represents the strength of our application and the tremendous dedication of our entire organization."

If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and pharmacovigilance.

LYTENAVA™ (bevacizumab gamma) has received marketing authorization from the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency in the UK for treating wet age-related macular degeneration. Outlook Therapeutics has commenced commercial launch in Germany, Austria, and the UK.

The drug is a recombinant humanized monoclonal antibody that binds to human vascular endothelial growth factor and neutralizes its biologic activity. Following intravitreal injection, it reduces endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.