Outlook Therapeutics has submitted a request for a Type A meeting with the US Food and Drug Administration (FDA) following receipt of the agency’s complete response letter (CRL) for ONS-5010, its investigational ophthalmic formulation of bevacizumab for neovascular (“wet”) age-related macular degeneration (nAMD).

The CRL, issued on August 27, cited a single deficiency: lack of substantial evidence of effectiveness. While the FDA acknowledged that the pivotal NORSE TWO trial met its safety and efficacy endpoints, the agency emphasized that the NORSE EIGHT study did not meet its primary endpoint and recommended submission of confirmatory evidence of efficacy. The requested Type A meeting is intended to clarify the details of the additional evidence required to support potential approval.

Bevacizumab (Avastin; Genentech) was originally approved for cancer treatment in 2004. It has been used off-label since around 2005 to treat nAMD, following early clinical evidence and physician reports suggesting its effectiveness in reducing retinal fluid and improving vision. ONS-5010 is designed as an on-label alternative to compounded bevacizumab. If approved, the product will be marketed in the United States as Lytenava (bevacizumab-vikg). ONS-5010 has already received marketing authorization in the European Union and the United Kingdom, with commercial sales beginning in Germany and the UK in June 2025. RP