Genentech Secures FDA Approval for Susvimo the First Long-Lasting Treatment for Diabetic Macular Edema

05 February 2025 | Wednesday | News

With as few as two treatments per year, Susvimo provides a breakthrough alternative to frequent eye injections, helping millions with diabetic macular edema preserve their vision.

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Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) –

– With as few as two treatments per year, Susvimo may help people with DME maintain their vision –

– Approval marks the second indication for Susvimo in addition to wet, or neovascular age-related macular degeneration (AMD) –

Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo^® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide. Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections. Susvimo is now available to U.S. retina specialists and their patients with DME.

Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As the global prevalence of this condition continues to grow, today's FDA approval for Susvimo reflects our dedication to innovation and enhancing the patient experience.”

“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,” said vitreoretinal surgeon, Jordan Graff, M.D., Barnet Dulaney Perkins Eye Center, Arizona. “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.”

The FDA decision was based on positive one-year results from the Phase III Pagoda study, which showed that Susvimo demonstrated sustained vision improvements in people with DME, with safety consistent with the known safety profile for Susvimo. In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively).

Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. Susvimo was first approved by the FDA for the treatment of wet, or neovascular age-related macular degeneration (AMD) in 2021.

Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement

Genentech Secures FDA Approval for Susvimo the First Long-Lasting Treatment for Diabetic Macular Edema

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