On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD. The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.
The study was conducted following Outlook’s receipt of a Complete Response Letter from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding additional clinical trials. Based on the results of the NORSE EIGHT trial, Outlook plans to resubmit its Biologics Licence Application (BLA) for ONS-5010 to the US FDA in the first quarter of 2025.
Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission to the MHRA under the International Recognition Procedure (IRP). The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024. Lytenava™ is the first authorised ophthalmic formulation of bevacizumab in the EU.