Roche’s cancer treatment Avastin (bevacizumab) has long been employed as an off-label option for wet age-related macular degeneration (AMD) patients. And now the FDA has endorsed a new formulation of the VEGF inhibitor for regulated use in the United States.
Bringing it to the market is New Jersey-based Outlook Therapeutics, which labored through three FDA rejections to finally secure a nod. Bevacizumab was approved as Lytenava in Europe and the U.K. in 2024 and will take on the same commercial name in the U.S.
With the approval, Outlook said it expects to gain 12 years of reference product market exclusivity as specified by 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,” Bob Jahr, the CEO of Outlook, said in a release. “Lytenava fundamentally changes that landscape. Rather than relying on repackaged formulations originally intended for intravenous use, physicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed specifically for intravitreal administration that delivers the manufacturing consistency, product quality, and regulatory oversight patients deserve.”
Outlook enters a massive U.S. market—estimated at $8.5 billion by the company—with only a few drugmakers splitting the pie. They include Roche with Vabysmo, Regeneron with Eylea and companies producing biosimilar versions of Novartis and Roche’s Lucentis.
The company has yet to disclose a launch date or what it will charge for Lytenava, which is dosed monthly. Outlook is "expanding reimbursement and patient support access along with building out its commercial organization in the U.S.," a spokesperson said in response to emailed questions.
Outlook reported sales of Lytenava at $1.4 million in its fiscal year of 2025, which ended in September. Sales more than doubled sequentially, the company said, in the first quarter.
After the FDA sent its third complete response letter (CRL) to Outlook in December, citing a lack of evidence in the effectiveness of bevacizumab, the company appealed with a formal dispute resolution (FDR) request.
In May, the FDA’s Office of New Drugs (OND) concluded that clinical trial results, coupled with natural history and other mechanistic and pharmacodynamic data, were enough to establish “substantial evidence of effectiveness” for the drug, Outlook explained. The decision allowed Outlook to resubmit its biologics license application early last month.
The decision was based on data from two trials, one which met its efficacy endpoint and another that didn’t. The endpoints for both studies were the same—to demonstrate non-inferiority with VEGF inhibitor Lucentis.
The FDA’s second CRL to Outlook, which came in August of last year, also centered on efficacy concerns based on the failed study. In the first CRL, which came in 2023, the FDA cited manufacturing and efficacy issues.
Roche gained approval for Avastin to treat colorectal cancer in 2004. Two years later, Novartis gained a nod for Lucentis, with the same mechanism of action, to treat wet AMD. With Avastin priced significantly lower—roughly $50 per dose compared to $2,000 per dose—physicians began prescribing it off label for wet AMD.
In 2011, a U.S. government-funded study found that Avastin matched the efficacy for Lucentis in wet AMD, even though Novartis claimed that it was not the same compound and needed to be manufactured differently. Complicating matters for Roche was its 2009 buyout of Genentech, the company which developed Avastin and Lucentis.