Key Takeaways

  • FDA’s Office of New Drugs determined that Outlook Therapeutics has established substantial evidence of effectiveness for Lytenava in treating wet AMD, clearing the way for a BLA resubmission in June 2026
  • The resubmission is expected to be classified as a Class 1 review, with a potential FDA decision anticipated within 60 days after the agency receives the application
  • If approved, Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases in the US

After several setbacks, Outlook Therapeutics announced Tuesday that the FDA has granted the company’s appeal following a Formal Dispute Resolution (FDR) process tied to its biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg), a proposed treatment for wet age-related macular degeneration (AMD).

The FDA’s Office of New Drugs (OND) concluded that Outlook Therapeutics has established “substantial evidence of effectiveness” for Lytenava in treating wet AMD, a major milestone that clears the way for the company to resubmit its BLA in June 2026.

The decision follows a December 30, 2025 Complete Response Letter (CRL) issued by the FDA regarding the company’s application. Outlook Therapeutics subsequently engaged in the FDR process after a Type A meeting with the FDA’s Division of Ophthalmology and Office of Specialty Medicine.

According to the company, the FDA's OND determined that data from the NORSE TWO clinical trial, combined with confirmatory evidence from NORSE EIGHT, natural history findings, and mechanistic and pharmacodynamic data, collectively demonstrated sufficient evidence of effectiveness for the therapy. The FDA also directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook on final labeling discussions. The company said the agency anticipates the resubmission will qualify as a Class 1 review, which typically carries a 60-day review timeline from the date of receipt.

“We appreciate the opportunity to engage with the FDA through the FDR process,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “The Agency’s action on our appeal provides a clear path forward toward US approval ... We have remained resolute that patients deserve additional FDA-approved options for the treatment of nAMD and look forward to receiving an approval decision for ONS-5010/Lytenava."

If approved, Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab manufactured specifically for ophthalmic use and supported by FDA-approved labeling and pharmacovigilance protocols. Bevacizumab has long been used off-label in ophthalmology for retinal diseases, including wet AMD, but no ophthalmic formulation has yet received FDA approval in the United States.

The positive news comes after the FDA issued three CRL's to Outlook dating back to 2023. Outlook’s product is already authorized in Europe and the United Kingdom under the name Lytenava (bevacizumab gamma). The therapy has received centralized Marketing Authorization from the European Commission and approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD. The company has also launched the product commercially in Germany, Austria, and the UK.