The US Food and Drug Administration issued a complete response letter for Outlook Therapeutics’ ONS-5010/LYTENAVA (bevacizumab-vikg) in wet age-related macular degeneration.

In the complete response letter for the resubmitted biologics license application, the FDA noted that NORSE TWO met its primary endpoint and identified no other deficiencies. The agency said it could not approve the application in its present form and requested confirmatory evidence after ONS-5010 failed the primary efficacy endpoint in NORSE EIGHT.

Outside the US, LYTENAVA (bevacizumab gamma) holds Marketing Authorization from the European Commission and from the Medicines and Healthcare products Regulatory Agency in the UK for treatment of wet age-related macular degeneration in adults. Commercial availability began in June 2025 in Germany and the UK. ONS-5010/LYTENAVA remains investigational in the US.

Bevacizumab-vikg (bevacizumab gamma in the European Union and UK) is a recombinant humanized monoclonal antibody that binds all isoforms of vascular endothelial growth factor (VEGF) with high affinity and prevents VEGF interaction with endothelial receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) following intravitreal injection, with the goal of reducing endothelial proliferation, vascular leakage, and neovascularization in the retina.

Source: Outlook Therapeutics