On July 24, 2026, Outlook Therapeutics announced the FDA approval of Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (“nAMD”), commonly known as wet AMD. According to Outlook, Lytenava™ is the first ophthalmic formulation of bevacizumab approved by the FDA for the treatment of wet AMD in the United States.

Lytenava™ is a vascular endothelial growth factor (“VEGF”) inhibitor and an ophthalmic formulation of bevacizumab administered by intravitreal injection. Although bevacizumab has been used off-label in ophthalmology, Avastin^® (bevacizumab) and its approved biosimilars are not approved by the FDA for wet AMD. Lytenava™ was approved for wet AMD through a standalone biologics license application, rather than as a biosimilar to Avastin^®.

The FDA approval of Lytenava™ provides an FDA-approved ophthalmic bevacizumab option for wet AMD, an indication treated with anti-VEGF products including Eylea^® (aflibercept) and Lucentis^® (ranibizumab). Outlook stated that the approval was supported by clinical and manufacturing information submitted in its biologics license application.

Outlook also stated that it anticipates 12 years of Reference Product Exclusivity for Lytenava™ under the Biologics Price Competition and Innovation Act. The company is proceeding with its U.S. commercial launch and expects to make Lytenava™ available in the United States before year-end.

Currently there are no pending patent disputes related to Lytenava™.

Outlook stated that the U.S. anti-VEGF retina market is estimated at approximately $8.5 billion annually.

For more information about these and other biologics, please visit BiologicsHQ.

_____________________________________________________

The authors would like to thank April Breyer Menon for her contributions to this article.