FDA Approves Susvimo for Diabetic Macular Edema

WEDNESDAY, Feb. 5, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema.

Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with diabetic macular edema with fewer treatments based on its continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform. The refillable implant is surgically inserted into the eye during a one-time, outpatient procedure.

The approval was based on positive one-year results from the phase 3 Pagoda study. In the trial, people with diabetic macular edema who received Susvimo refilled every six months achieved noninferior improvements in vision compared with those receiving monthly 0.5-mg ranibizumab intravitreal injections (9.6 and 9.4 eye chart letters, respectively). The most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure, while the most common nonocular side effects included nasopharyngitis, anemia, nausea, and cough.

"I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives," Jordan Graff, M.D., from the Barnet Dulaney Perkins Eye Center in Phoenix, said in a statement. "Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration, I've seen firsthand how Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments. I look forward to broadening Susvimo's impact to even more patients in my clinic."

Approval of Susvimo was granted to Genentech.

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