Outlook Therapeutics completed a Federal Dispute Resolution meeting with the FDA regarding the CRL for its ONS-5010/LYTENAVA™ BLA for wet AMD, with a formal decision expected in May 2026.
Key takeaways
Outlook Therapeutics completed a Federal Dispute Resolution meeting with the FDA's Office of New Drugs regarding the December 30, 2025 CRL for ONS-5010/LYTENAVA™.
The meeting was part of ongoing efforts to seek alignment on the regulatory pathway for the investigational wet AMD treatment.
The company expects to receive formal feedback from the FDA in May 2026 regarding the BLA resubmission.
ONS-5010/LYTENAVA™ is an ophthalmic bevacizumab formulation already authorized in the EU and UK for wet AMD treatment.
If approved in the US, ONS-5010/LYTENAVA™ would be the first approved ophthalmic bevacizumab formulation for retinal indications.