The U.S. Food and Drug Administration has approved Lytenava, a novel ophthalmic formulation of the anti-VEGF drug bevacizumab, for the treatment of wet age-related macular degeneration. The decision marks the first time an FDA-approved version of bevacizumab has been cleared specifically for use in this chronic, progressive retinal disease, a leading cause of severe vision loss among older adults worldwide.
The approval follows three previous rejections by the agency, including complete response letters issued in 2023 and two in 2025. The most recent rejection, in December 2025, cited a lack of substantial evidence of effectiveness. In response, Outlook Therapeutics filed a formal dispute resolution request with the FDA’s Office of New Drugs. After review, the office determined that combined data from the company’s NORSE TWO and NORSE EIGHT studies, along with supplemental information from other trials, provided sufficient evidence to support approval.
While NORSE EIGHT did not meet its primary endpoint of non-inferiority compared to a formulation of ranibizumab, the NORSE TWO study did achieve that goal. Historically, compounded versions of bevacizumab have been used off-label for wet AMD because the original drug, Roche’s Avastin, is only approved for cancer. With Lytenava, ophthalmologists now have an FDA-approved option designed specifically for intravitreal injection. “For more than two decades, bevacizumab has served as one of the most widely utilised anti-VEGF therapies in retina care, despite the absence of an FDA-approved ophthalmic formulation,” said Bob Jahr, chief executive of Outlook Therapeutics. “Lytenava fundamentally changes that landscape.”
The U.S. wet AMD market is estimated to be worth approximately $8.5 billion annually, currently dominated by Regeneron’s Eylea, Roche’s Vabysmo, off-label bevacizumab, and ranibizumab products. Outlook expects to launch Lytenava in the U.S. before the end of this year. Pricing has not yet been disclosed, though in the UK the drug is listed at £470 per vial, translating to an annual cost of roughly £3,290 to £4,230 for a typical course of seven to nine injections.
In related regulatory news, Roche’s refillable implant formulation of ranibizumab, Susvimo, has been recommended for approval in the European Union for adults with wet AMD. First launched in the U.S. in 2021, Susvimo was withdrawn in 2022 due to manufacturing defects and re-launched in 2024. It is also now approved in the U.S. for diabetic macular oedema, another leading cause of vision loss. For patients with wet AMD, these approvals signal a growing array of treatment options that combine efficacy with greater convenience and regulatory oversight.