On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet AMD.
Earlier this month, Outlook Therapeutics announced that it had launched Lytenava™ in the UK and Germany for wet AMD. Lytenava™ is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the UK.
Lytenava™ (also known as ONS-5010, bevacizumab-vikg/bevacizumab gamma) received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP). Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.
Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.