FDA approves Roche’s Susvimo as first continuous delivery treatment for Diabetes-Related Blindness

Roche announced that the US 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 US 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, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. “As the global prevalence of diabetic macular edema 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, MD, Barnet Dulaney Perkins Eye Center, Arizona, US. “Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration (nAMD), I’ve seen first-hand 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.⁷ 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 customised 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 nAMD in 2021. Discussions with other global regulatory agencies are ongoing.

Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies and has the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye conditions.

About diabetic macular edema (DME)
Affecting around 29 million people globally, DME is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases.