How Lytenava's FDA approval will impact clinical treatment of nAMD

Outlook Therapeutics, Inc, recently announced the US FDA approval of Lytenava (bevacizumab-vikg; Outlook Therapeutics) for the treatment of neovascular age-related macular degeneration (nAMD).¹ In an exclusive interview with Optometry Times, Carolyn Majcher, OD, FAAO, Associate Professor at Northeastern State University Oklahoma College of Optometry, discussed how the recent approval will impact clinician’s approach to nAMD management.

Compounded bevacizumab has been “utilized off-label in clinical practice…extensively for years on end”, according to Majcher. For optometrists, the recent FDA approval instills confidence in the use of the FDA-approved product in the treatment of nAMD.

For the approval process, Lytenava underwent extensive randomized and controlled clinical trials, collecting “evidence of efficacy in neovascular AMD [treatment]” Majcher said. “The FDA is evaluating more than just the drug bevacizumab itself and its clinical efficacy, but rather they're also ensuring that Lytenava, the commercial formulation itself, is meeting the standards for consistent manufacturing, product quality, sterility, stability, appropriate market labeling,” she continued. Adherence to research guidelines and safety guidelines required by the FDA assures providers that they are recommending high quality treatment options for their patients.

Currently, Lytenava is only FDA-approved for nAMD. Majcher points out that there are several other ocular diseases that do not fall under it’s current scope. Since off-label bevacizumab is currently the most affordable option, it is unlikely that Lytenava will completely take it’s place. Additionally, it’s application in clinical use will depend on a number of economic factors, such as “insurance reimbursements [and] pre-authorization” Majcher said.

Additionally, Majcher discussed how Lytenava fits in the realm of other nAMD treatment options. Currently, “newer-generation anti-VEGF agents, such as Vabysmo or Eylea HD…offer an extended duration of action,” according to Majcher. She anticipates that these will remain the standard of care option for providers if “on-label bevacizumab or other products” fail.

References

1. Outlook Therapeutics announces Lytenava^TM FDA approval as the first and only FDA-approved opthalmic bevaccizumab for the treatment of wet AMD. Published July 25, 2026. Accessed August 19, 2026. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-lytenavatm-fda-approval-first-and