On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the treatment of wet AMD.
The resubmission is based on positive results of the NORSE EIGHT clinical trial, announced in January 2025, which 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 (CRL) from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials. Additional chemistry, manufacturing and controls (CMC) information requested by the FDA has also been included in the resubmission.
Lytenava™ was approved in the UK for wet AMD in July 2024 following submission of a marketing authorisation application 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.