FDA Approves Susvimo for Treatment of Diabetic Retinopathy

The US Food and Drug Administration (FDA) has approved Susvimo 100 mg/mL, a ranibizumab injection administered via the Port Delivery System (PDS), to treat diabetic retinopathy (DR).1

Announced by Genentech, a member of the Roche Group, on May 22, 2025, Susvimo is the first and only FDA-approved continuous delivery treatment capable of maintaining vision in people with DR through one refill every 9 months.1

“Susvimo is a compelling new treatment for patients at risk of vision loss from progression of DR,” said vitreoretinal surgeon Carl Awh, MD, Tennessee Retina. “I am delighted to have this far more durable treatment available for my patients.”1

DR accounts for roughly 5% of all cases of visual impairment worldwide. It occurs when damage to blood vessels and the formation of new blood vessels causes blood and/or fluid to leak into the retina. This triggers the swelling and blockage of blood supply to some areas of the retina. DR affects roughly 103 million people globally, leading to blindness in almost 5 million.1

DR is the third approved indication for Susvimo; in February 2025, the FDA approved it for treating diabetic macular edema based on results from the Phase 3 Pagoda study. At that time, it was also the first and only FDA-approved DME treatment to maintain vision with fewer injections than the standard of care.3

The FDA’s approval was based on positive results from the Phase 3 Pavilion study, a multicenter, randomized, US-based study evaluating the efficacy and safety of Susvimo 100 mg/mL in treating DR. In the trial, patients were randomized 5:3 to PDS Q36W or control. The first cohort was given 2 ranibizumab 0.5 mg loading doses before the PDS was implanted at Week 4. The control cohort was given standard-of-care until Week 60 and received 2 ranibizumab loading doses before PDS implantation at Week 64. Additionally, both cohorts could receive supplemental ranibizumab 0.5 mg treatment at each study visit, except for refill exchanges.1,2

In the PDS Q36W cohort (n = 106), approximately 80% (95% CI, 72.6-87.8) of patients achieved a ≥2-step diabetic retinopathy severity score (DRSS) improvement from baseline to Week 100. Only 2% of patients were given supplemental treatments. The control arm saw 91.7% (95% CI, 80.6-100) of implanted patients reaching ≥2-step DRSS improvement at Week 100. No patients in this cohort received supplemental treatment. Safety was consistent with the known profile for Susvimo through Week 100.2

According to Genentech’s press release, the medication is now available to US retina specialists for use in patients with DR who have responded to at least two anti-vascular endothelial growth factor (anti-VEGF) injections.1

“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.”1

References

1. Roche. FDA approves Roche’s Susvimo for diabetic retinopathy. May 22, 2025. Accessed May 22, 2025. https://www.roche.com/media/releases/med-cor-2025-05-22

2. Iapoce, C. Margaret Chang, MD: Two-Year Outcomes of the PDS for Diabetic Retinopathy. July 22, 2024. Accessed May 22, 2025. https://www.hcplive.com/view/margaret-chang-md-two-year-outcomes-of-the-pds-for-diabetic-retinopathy

3. Iapoce, C. FDA Approves Susvimo for Diabetic Macular Edema. February 4, 2025. Accessed May 22, 2025. https://www.hcplive.com/view/fda-approves-susvimo-for-diabetic-macular-edema