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FDA Approves Roche’s Vabysmo® (Faricimab) in PFS

Jul 5, 2024

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.