Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™ (ONS-5010, bevacizumab gamma), has been recommended by the National Institute for Health and Care Excellence (NICE) as a NHS treatment option for wet age-related macular degeneration (AMD).
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.
Outlook Therapeutics is currently undertaking a clinical trial to assess the effectiveness of Lytenava™ for use in wet AMD for the purpose of resubmission of its Biologics Licence Application to the US FDA. This follows receipt of a Complete Response Letter from the FDA and submission of a Special Protocol Assessment (SPA) request in 2023.