On 30 July 2024, Roche announced that the European Commission has approved Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion (RVO). This follows the positive CHMP opinion for the indication in June 2024.
This is the first approval for a bispecific antibody treatment for RVO, and the third indication approval for Vabysmo®, in the EU.
One day earlier, Vabysmo® was approved for RVO in Canada. Vabysmo® has also been approved for RVO in the US (in October 2023) and Japan (in March 2024) . It is approved in nearly 100 countries for nAMD and diabetic macular oedema.