FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema

Credit: Fernando Cortés | stock.adobe.com

The FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant to treat diabetic macular edema (DME).¹ In clinical trials, patients with DME who received the refillable eye implant showed sustained vision improvements while requiring fewer treatments than standard eye 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,” vitreoretinal surgeon, Jordan Graff, MD, Barnet Dulaney Perkins Eye Center, Arizona, US, said in a press release. “Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration, 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.”¹

Susvimo was designed to provide continuous delivery of a customized formulation of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor. The drug attaches to and inhibits VEGF-A, which research has found to play a crucial role in forming new blood vessels and in the leakiness of these vessels, according to Roche.

The customized formulation of the drug that Susvimo delivers is different from the intravitreal injection, which is approved under the brand name Lucentis for the treatment of neovascular, or wet, age-related macular degeneration, as well as other retinal conditions.

The efficacy of Susvimo was shown in two-year data from the confirmatory Phase III Pagoda trial (NCT04108156)² for the treatment of DME, as well as the Phase III Pavilion trial (NCT04503551) for diabetic retinopathy (DR).³

The multicenter, randomized, visual assessor-masked, active-comparator Pagoda trial analyzed Susvimo refilled every six months vs. monthly administration of ranibizumab 0.5 mg intravitreal injections in 634 patients with DME. The trial’s primary endpoint was change in best-corrected visual acuity score from baseline at weeks 60 and 64.

Susvimo refilled every six months was found non-inferior in vision improvements compared to monthly ranibizumab intravitreal injections, at 9.6 eye chart letters vs. 9.4 letters, which investigators said equates to gaining two more lines on an eye chart.

Findings released in July 2024 show that patients maintained vision gain improvements at one year with 9.8 eye chart letters. Approximately 95% of patients did not require additional supplemental injections.⁴

The multicenter, randomized Pavilion trial enrolled patients with DR without center-involved DME. Patients in the Susvimo cohort received 100 mg/mL refilled every nine months to compare with individuals receiving monthly clinical observation. The trial’s primary endpoint was proportion of patients showing at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (DRSS) at week 52.

Two-year data found that at week 100, 80% of patients administered Susvimo achieved a two-step or higher improvement on the DRSS from pre-implant baseline. Those administered Susvimo at week 64 were found to maintain or improve their DRSS score from pre-implant baseline.

“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” Levi Garraway, MD, PhD, Roche chief medical officer and head of Global Product Development, said in a press release. “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.”¹

References

1. FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness. News release. Roche. February 4, 2025. Accessed February 4, 2025. https://www.roche.com/media/releases/med-cor-2025-02-04

2. A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab A Subtudy to Evaluate the Safety of Re-Implanting the PDS With Ranibizumab in Participants With DME (Pagoda). ClinicalTrials.gov. Updated October 15, 2024. Accessed February 4, 2025. https://clinicaltrials.gov/study/NCT04108156

3. A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm (PAVILION). ClinicalTrials.gov. Updated January 17, 2025. Accessed February 4, 2025. https://clinicaltrials.gov/study/NCT04503551

4. New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions. News release. Roche. July 18, 2024. Accessed February 4, 2025. https://www.roche.com/media/releases/med-cor-2024-07-18