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Roche: new FDA approval for Vabysmo

( - Roche has announced that the US FDA has accepted its supplemental Biologics License Application (sBLA) for Vabysmo (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO).

The sBLA is based on results from phase III studies that demonstrated that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferiority to aflibercept.

If approved, RVO would be the third indication for Vabysmo in addition to neovascular or "wet" age-related macular degeneration and diabetic macular oedema, diseases for which it is currently approved in 60 countries.

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