Key Takeaways

  • The FDA approved Lytenava (bevacizumab-vikg) for wet AMD, making it the first FDA-approved ophthalmic formulation of bevacizumab in the US
  • The approval provides an ophthalmic bevacizumab specifically developed for intravitreal administration, replacing reliance on repackaged intravenous formulations
  • Outlook Therapeutics plans a US commercial launch before year-end, supported by reimbursement and patient assistance programs

The FDA has approved Outlook Therapeutics' Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD), making it the first FDA-approved ophthalmic formulation of bevacizumab in the United States.

According to Outlook, the approval provides retina specialists with an ophthalmic bevacizumab specifically developed for intravitreal use, rather than relying on repackaged formulations originally intended for intravenous administration. Outlook said the product is supported by clinical data, validated manufacturing processes, FDA-approved labeling, and ongoing regulatory oversight. The company also expects Lytenava to receive 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act (BPCIA).

"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," said Bob Jahr, chief executive officer of Outlook Therapeutics. "Lytenava fundamentally changes that landscape."

Bevacizumab has long been used off-label as an anti-VEGF therapy for retinal diseases because of its comparatively low cost, despite lacking an FDA-approved ophthalmic formulation. Outlook Therapeutics said the approval establishes a new regulatory standard for ophthalmic bevacizumab and could support broader adoption of an FDA-approved product specifically manufactured for ocular use.

The approval comes 2 months after the FDA granted Outlook's appeal following a Formal Dispute Resolution (FDR) process tied to its biologics license application (BLA) for ONS-5010/Lytenava. The FDA’s Office of New Drugs (OND) concluded that Outlook established “substantial evidence of effectiveness” for Lytenava in treating wet AMD, a major milestone that cleared the way for the company to resubmit its BLA. That decision followed a December 30, 2025 Complete Response Letter (CRL) issued by the FDA regarding the company’s application. Altogether, the FDA issued three CRL's for the drug dating back to 2023. 

Outlook Therapeutics said it is preparing for the commercial launch of Lytenava by expanding reimbursement and patient support programs, building its retina-focused commercial organization, and working with physicians across the United States. The company expects the product to become available to eligible US patients before the end of the year. The product is already authorized in Europe and the United Kingdom under the Lytenava brand.