9 May 2023 - Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to aflibercept.
Genentech today announced that the US FDA has accepted the company’s supplemental biologics license application for Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion.