On 13 December 2024, Roche announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6mg) for treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO).
Vabysmo® was first approved in the US in January 2022 in a vial format and is available in multiple countries, including Europe, Canada and Australia. Vabysmo® PFS for nAMD, DME and RVO was approved by the US FDA in July 2024.