FDA Approves LYTENAVA™: A New Era for Wet AMD Treatment

Iselin, N.J. – July 24, 2026 – The inherited retinal disease (IRD) community, and particularly those affected by age-related macular degeneration (AMD), are seeing a significant development with the U.S. Food and Drug Administration (FDA) approval of LYTENAVA™ (bevacizumab-vikg) by Outlook Therapeutics. This landmark approval marks LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of neovascular (wet) age-related macular degeneration in the United States.

Wet AMD is a chronic and progressive retinal disease that is a leading cause of severe vision loss among older adults, significantly impacting central vision needed for daily activities like reading and driving. While bevacizumab has been widely used off-label in retina care for over two decades, often repackaged from oncology formulations, this approval means patients and physicians now have access to a purpose-built ophthalmic formulation developed specifically for intravitreal administration.

Key Facts about LYTENAVA™ Approval

First and Only FDA-Approved Ophthalmic Bevacizumab: LYTENAVA™ is the first bevacizumab formulation specifically approved by the FDA for ophthalmic use in treating wet AMD.
Developed for Intravitreal Use: Unlike previous off-label uses, LYTENAVA™ is designed and manufactured specifically for injection into the eye, ensuring consistency, product quality, and regulatory oversight.
Long Journey to Approval: Outlook Therapeutics faced multiple Complete Response Letters (CRLs) from the FDA since its initial submission in 2022, but ultimately secured approval after an appeal process.
Anticipated Market Exclusivity: Outlook Therapeutics anticipates 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (BPCIA).
Commercial Launch Expected Soon: Outlook Therapeutics expects to make LYTENAVA™ available to eligible patients in the U.S. before the end of 2026.

What This Means for Patients and Families

For patients and families navigating the challenges of wet AMD, this approval offers a new, standardized, and FDA-regulated treatment option. The availability of an ophthalmic bevacizumab developed specifically for the eye, backed by rigorous clinical evidence and validated manufacturing, provides reassurance regarding its purity, potency, and safety. This could lead to greater confidence in treatment outcomes and potentially improve access to a well-established anti-VEGF therapy.

Bob Jahr, CEO of Outlook Therapeutics, highlighted the significance, stating,