Outlook Therapeutics has secured FDA approval for Lytenava, a reformulated ophthalmic version of Roche’s widely used cancer and eye treatment bevacizumab, after three prior rejections.
The New Jersey-based company received the greenlight on July 24, 2026, making Lytenava the first FDA-approved ophthalmic formulation of bevacizumab for wet age-related macular degeneration.
Bevacizumab has been used off-label for wet AMD for more than two decades, becoming one of the most common anti-VEGF therapies in retina care despite lacking a formal ophthalmic approval.
“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, CEO of Outlook Therapeutics.
The drug, already approved under the Lytenava name in Europe and the UK in 2024, will carry the same commercial branding in the United States following this week’s decision.
Outlook expects to launch Lytenava in the US before the end of this year, with the treatment designed to be administered once a month.
The company also anticipates receiving 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act, which could significantly shield the drug from biosimilar competition.
The road to approval was far from straightforward, with the FDA having previously rejected Lytenava in 2023 over manufacturing concerns and the need for additional clinical evidence to support its effectiveness.
Following that rejection, Outlook conducted a second phase 3 trial called Norse Eight, comparing Lytenava against Roche and Novartis’ Lucentis, another anti-VEGF agent approved for wet AMD and other eye conditions.
The Norse Eight trial did not meet its prespecified noninferiority endpoint at eight weeks, prompting a second FDA rejection in August that cited the primary efficacy endpoint miss and called for more confirmatory evidence.
Outlook refiled based on a 12-week analysis showing Lytenava produced a mean improvement of 5.5 letters in best corrected visual acuity, compared with 6.5 letters for Lucentis, arguing the data demonstrated substantial effectiveness.
After its third rejection, Outlook initiated a formal dispute resolution process, which ultimately led the FDA Office of New Drugs to grant an appeal and agree that substantial evidence of effectiveness had been established.
Outlook is now moving forward with a commercial launch that includes expanding reimbursement access, building a specialised retina commercial organisation, and supporting physicians across the country.
The company described the approval as establishing a new benchmark for ophthalmic bevacizumab, positioning Lytenava as what it called the new FDA-approved standard for bevacizumab therapy in wet AMD patients.