On 5 July 2024, Roche announced that the FDA has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6 mg) for nAMD, diabetic macular oedema and macular oedema following retinal vein occlusion. Roche reports that the product is the first PFS with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness.
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. In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.