FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

Genentech announced that the U.S. FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Wet AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month. Susvimo, previously called Port Delivery System with ranibizumab, offers as few as two treatments per year.

The approval is based on positive results from the Phase III Archway study primary analysis. The randomized, multicenter, open-label study evaluated the efficacy and safety of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant administered via the Susvimo eye implant, refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 415 patients with wet AMD. Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archw...

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