New application alert: FDA accepts Roche’s sBLA for Vabysmo® (faricimab)

May 9, 2023

Roche announced that the FDA has accepted its sBLA for Vabysmo® (faricimab) to treat macular edema following retinal vein occlusion.  The sBLA is based on results from the phase III BALATON and COMINO studies which met primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

Last year, Health Canada approved Vabysmo® for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.

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