Outlook Therapeutics has won the difficult battle to commercialize the ophthalmic version of Roche’s Avastin (bevacizumab) in the United States, with the FDA now agreeing that the drug has demonstrated efficacy as a treatment for wet age-related macular degeneration.
The FDA’s change of heart comes after it granted an appeal of a formal dispute resolution (FDR) request initiated last month following Outlook’s third rejection of Lytenava (ONS-5010).
As a result of the process, the FDA’s Office of New Pharmacy (OND) concluded that the clinical trial results and natural history and other mechanistic and pharmacodynamic data were sufficient to establish “substantial evidence of efficacy” for the drug, Outlook explained in a release on Tuesday.
The formal dispute process is a little-known route that pharmaceutical companies can use as a structured way to raise concerns with the FDA.
The decision provides that Outlook may resubmit Rinteva’s biologics license application, with an FDA decision date within 60 days of receipt of the resubmission.
Outlook said it plans to resubmit next month. The company’s stock was up 29% at market close on Tuesday.
“We appreciate the opportunity to engage with FDA through the FDR process,” said CEO Bob Jahr. “The agency’s action on our complaint provides a clear path toward U.S. recognition.”
The latest rejection of the bevacizumab product in December came in the form of a full response letter requesting additional confirmatory evidence of efficacy, but the agency “has not indicated what type of confirmatory evidence will be accepted,” Outlook noted at the time.
Two months later, the company requested a Type A meeting to resolve the issue with the FDA, arguing that the decision was “inconsistent with the totality of the evidence” used in the application. Also, Outlook was surprised by this. The company said it has operated with the belief that it is consistent with the FDA regarding drug applications based on prior discussions.
The FDA rejected the drug for the second time in August due to errors in the primary efficacy endpoint in Outlook’s Norse Eight study, just months before the previous resubmission, and recommended more supporting evidence of efficacy. North Eight had run in 2023 as a result of Linenava’s initial refusal.
The FDA’s initial disdain was related to manufacturing issues as well as the need for further confirmatory evidence. Outlook has since learned about Lytenava’s manufacturing, describing the product as being supported by a “domestic, end-to-end U.S. manufacturing supply chain.”
If approved, Ritenava would be the first bevacizumab eye drops in the United States and could enter a market comparable to Roche’s Avastin, which already has a long history of use as an off-label treatment for wet AMD. Regulators in Europe and the UK have already approved the drug.
