Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL as the first and only continuous delivery treatment for diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. This groundbreaking approval provides a less burdensome alternative to standard-of-care eye injections, which often require monthly administration. Susvimo offers the potential to maintain vision with as few as two treatments annually.
“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.”
The FDA’s approval is based on the positive one-year results from the Phase III Pagoda study, which demonstrated that Susvimo provided sustained vision improvements in people with DME, achieving non-inferior outcomes compared to monthly ranibizumab 0.5 mg intravitreal injections. The innovative delivery system uses a refillable eye implant that consistently delivers a customized formulation of ranibizumab.
In the Pagoda trial, patients treated with Susvimo experienced significant benefits, such as:
- Comparable vision clarity improvement (9.6 letters on the eye chart) as with monthly injections.
- Extended intervals between treatments, maintaining effective outcomes with refills every six months.
“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 Jordan Graff, MD, vitreoretinal surgeon at Barnet Dulaney Perkins Eye Center, Arizona.
About Susvimo and the Pagoda Study
Susvimo is a surgically inserted, refillable eye implant that continuously delivers medication over time, eliminating the need for frequent injections. It works by delivering a customized formulation of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor that blocks the formation of abnormal blood vessels and leakage in the retina, which causes swelling and vision loss in DME.
In the Pagoda study, a randomized, active-controlled Phase III trial, 634 patients with DME were evaluated for the efficacy and safety of Susvimo compared to monthly ranibizumab injections. The trial demonstrated that Susvimo offers comparable vision improvements with fewer treatments, achieving its primary endpoint of change in best-corrected visual acuity (BCVA) score from baseline.
Addressing a Growing Need
DME affects approximately 29 million people worldwide and can lead to severe vision impairment or blindness when untreated. As the prevalence of diabetes continues to increase globally, innovative treatments like Susvimo are essential for reducing the burden of vision loss and improving quality of life for individuals with retinal diseases.
Roche’s broad retina pipeline includes groundbreaking therapies like Susvimo, which was first approved for neovascular or ‘wet’ age-related macular degeneration (nAMD) in 2021. Discussions with other global regulatory agencies regarding this new indication for Susvimo are ongoing.
With its continuous medication delivery and reduced treatment intervals, Susvimo is set to transform the standard of care for both DME and nAMD, offering convenience and improved outcomes for patients.
