The US Food and Drug Administration (FDA) has approved Lytenava (bevacizumab-vikg; Outlook Therapeutics) for the treatment of neovascular age-related macular degeneration (nAMD), making it the first FDA-approved ophthalmic formulation of bevacizumab in the United States.

Bevacizumab has been widely used off label for intravitreal treatment of retinal disease for more than 2 decades through compounded formulations prepared from the intravenous oncology product (Avastin; Genentech). Lytenava was developed specifically for ophthalmic use and is manufactured for intravitreal administration.

According to Outlook Therapeutics, the approval is supported by clinical trial data, FDA-reviewed manufacturing, and product labeling specific to ophthalmic use. The company also said it expects the product to receive 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act.

“For more than two decades, bevacizumab has served as one of the most widely utilized anti-VEGF therapies in retina care despite the absence of an FDA-approved ophthalmic formulation,” Bob Jahr, chief executive officer of Outlook Therapeutics, said in a statement.

Outlook Therapeutics said it is preparing for a US commercial launch, including reimbursement and patient support programs, and expects Lytenava to become available before the end of 2026. The product has also received marketing authorization in the European Union and the United Kingdom, although reimbursement decisions remain pending in certain European markets. RP