On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD. Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.
Lytenava™ (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.
Outlook Therapeutics has entered into a strategic collaboration with Cencora in relation to the commercial launch of Lytenava™ globally. In Europe, Cencora provides launch support including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics, distribution and field solutions.
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.