On 4 September 2024, Outlook Therapeutics announced that it has completed patient enrolment in its NORSE EIGHT clinical trial assessing the effectiveness of ONS-5010/Lytenava™ (bevacizumab-vikg, bevacizumab gamma) for use in wet AMD. The trial is the final step required before expected resubmission of Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010 in the US, following receipt of a Complete Response Letter from the FDA, and submission of a Special Protocol Assessment (SPA) request, in 2023. The drug has the potential to be the first US-approved ophthalmic formulation of bevacizumab.
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.