FDA accepts application for Genentech’s Vabysmo for the treatment of retinal vein occlusion

Genentech

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.

Read Genentech press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier