Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin (bevacizumab) in the U.S., with the FDA now agreeing that the drug has demonstrated its effectiveness as a treatment for wet age-related macular degeneration.
The FDA’s change of heart comes after it granted an appeal of Outlook’s formal dispute resolution (FDR) request, which the company initiated last month following its third rejection of Lytenava (ONS-5010).
As a result of the proceedings, 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 in a Tuesday release.
A formal dispute process is a somewhat lesser-known pathway that drugmakers can use as a structured method for appealing FDA concerns.
The decision stipulates that Outlook can resubmit its biologics license application for Lynteva, which will be given an FDA decision date that should fall within 60 days of receipt of resubmission.
Outlook expects to file the resubmission next month, it said. The company’s share price soared upwards of 29% at market close on Tuesday.
“We appreciate the opportunity to engage with the FDA through the FDR process,” CEO Bob Jahr said. “The Agency’s action on our appeal provides a clear path forward toward U.S. approval.”
The bevacizumab product’s latest rejection in December came in the form of a complete response letter that asked for additional confirmatory evidence of efficacy, although the agency had not “indicated what type of confirmatory evidence would be acceptable,” Outlook pointed out at the time.
Two months later, the company requested a Type A meeting to sort out the issue with the FDA, contending that the decision was “inconsistent with the totality of evidence” leveraged in the application. It also took Outlook by surprise: Based on prior discussions, the company said it had been operating under the belief that it was in alignment with the FDA on the drug submission.
It was only a few months before the last resubmission that the FDA had denied the drug for the second time in August, citing a primary efficacy endpoint miss in Outlook’s Norse Eight study and recommending more confirmatory evidence of efficacy. Norse Eight had been run as a result of Lynenava’s first rejection in 2023.
That initial FDA snub concerned manufacturing issues as well as the need for further confirmatory evidence. Outlook has since gotten a handle on its Lytenava manufacturing and describes the product as supported by a “domestic, end-to-end U.S. manufacturing supply chain.”
If approved, Lytenava would become the U.S.’s first ophthalmic formulation of bevacizumab and could enter a market that has already warmed up to Roche’s Avastin, as the cancer drug has a long history of being used as an off-label treatment for wet AMD. Regulators in Europe and the U.K. have already signed off on the drug.