Got a patient with DME? Say goodbye to the monthly jab—Susvimo, the first continuous drug delivery system for DME just scored FDA approval.
On February 4, 2025, the U.S. Food and Drug Administration (FDA) approved Susvimo® (ranibizumab injection; Genentech/Roche; California, USA) for the treatment of diabetic macular edema (DME), making it the first and only anti-VEGF port delivery treatment for this leading cause of diabetes-related blindness.
Dr. Arshad M. Khanani expresses his excitement over the approval.
Currently, DME is often managed with frequent intravitreal injections—sometimes as often as once a month—of anti-vascular endothelial growth factor (anti-VEGF) medications. These injections help reduce fluid buildup in the retina and preserve vision but require repeated visits to an eye specialist, which can be burdensome for patients.
Susvimo offers an alternative approach: a surgically implanted device that delivers ranibizumab continuously and requires refills just twice a year. The device provides a sustained release of medication, potentially improving adherence to treatment while maintaining vision outcomes.
“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said Dr. Levi Garraway, chief medical officer and head of Global Product Development at Genentech, in a news release. “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.”
The FDA approval was based on positive one-year results from the Phase III Pagoda study, which evaluated Susvimo’s efficacy and safety compared to standard monthly ranibizumab injections.
Findings from the study showed that patients who received Susvimo every six months had vision improvements comparable to those receiving monthly injections. On average, Susvimo patients gained 9.6 letters on an eye chart, similar to the 9.4 letters gained by those receiving monthly injections.
“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 Dr. Jordan Graff, a vitreoretinal surgeon at Barnet Dulaney Perkins Eye Center in Arizona.
This latest approval marks the second indication for Susvimo. The treatment was first FDA-approved in 2021 for wet or neovascular age-related macular degeneration (nAMD), another serious retinal disease that causes vision loss.
As the prevalence of diabetes continues to rise, the number of people affected by DME is expected to grow. The approval of Susvimo offers a new, less burdensome treatment option for patients managing this condition, potentially improving their quality of life while helping preserve their vision.
