The FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for treating patients with diabetic retinopathy (DR). The regulatory action makes Susvimo the first and only FDA-approved continuous delivery therapy for DR.

What Makes Susvimo a Breakthrough in Diabetic Retinopathy Care?
The therapy offers a significant advancement with just one refill every nine months, providing sustained vision benefits in patients who have previously responded to at least two anti-VEGF injections, according to Roche. Approval was based on positive one-year data from the Phase III Pavilion study, which demonstrated superior improvement on the Diabetic Retinopathy Severity Scale (DRSS) and a reduced need for supplemental treatment compared to standard care.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, head, global product development, Roche, in a press release. “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.”

Study Design Focused on Long-Term Vision Preservation
The multicenter, randomized Pavilion study evaluated the efficacy, safety, and pharmacokinetics of Susvimo in 174 patients under monthly clinical observation. Participants were randomized in a 5:3 ratio to receive either Susvimo with refills every nine months or be placed in a control group under monthly observation without active treatment.

In the treatment arm, participants received two initial Susvimo injections prior to undergoing Susvimo implantation at week four. The primary endpoint of the study was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale at week 52. Following the primary analysis, participants in the control group were offered the same initial Susvimo injections as those in the treatment group.1

Pavilion Trial Demonstrates Superior Efficacy and Favorable Safety Profile
Results published in the National Center for Biotechnology Information found that at week 52, 80.1% of participants in the treatment group achieved at least a two-step improvement on the DRSS compared to 9% in the control group. The rate of progression to vision-threatening complications, including center-involved diabetic macular edema, proliferative diabetic retinopathy, or anterior segment neovascularization, was 7.1% in the treatment group and 47% in the control group, corresponding to a hazard ratio of 0.12 (P < .001).

Best-corrected visual acuity (BCVA) remained stable or improved slightly in the treatment group at +1.4 letters, while it declined at –2.6 letters in the control group. A transient BCVA reduction of 7.4 letters was observed in the treatment group four weeks post-implantation but resolved within eight weeks.

The treatment demonstrated a favorable safety profile, with notable ocular adverse events (AEs) reported in 16.2% of the treatment group, including cataract and vitreous hemorrhage, which were the most common AEs.2

Diabetic Retinopathy Continues to Grow as a Public Health Burden
According to a 2021 study published in JAMA Ophthalmology, approximately 9.6 million people in the United States had DR, while 1.84 million people also had vision-threatening DR. Between 2004 and 2021, the number of people over 40 years of age living with diabetes-related eye disease nearly doubled.

The study also found that one in four Americans over 40 years of age with diabetes were also living with DR. Prevalence increased with age up to a certain point but then declined in older populations, likely due to increased mortality rates.3

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

References

1. FDA approves Roche’s Susvimo for diabetic retinopathy. Roche. May 21, 2025. Accessed May 22, 2025. https://www.roche.com/media/releases/med-cor-2025-05-22

2. Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema. NIH. March 6, 2025. Accessed May 22, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC11886866/?utm_source=chatgpt.com

3. Diabetic Retinopathy. Prevent Blindness. Accessed May 22, 2025. https://preventblindness.org/prevalence-of-diabetic-retinopathy-vehss/