Susvimo Demonstrates Sustained Efficacy Over Two Years in Patients with Diabetic Macular Edema and Diabetic Retinopathy

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Two-year data from the Phase III Pagoda and Pavilion studies demonstrate that Genentech’s Susvimo (ranibizumab) injection 100 mg/mL produced sustained efficacy in patients with diabetic macular edema (DME) and diabetic retinopathy (DR), respectively. The FDA accepted a supplemental Biologics License Application (sBLA) for Susvimo based on one-year results showing non-inferior visual acuity gains in DME and superior improvements in the Diabetic Retinopathy Severity Scale (DRSS) for DR, compared to standard treatments.¹

“These efficacy and safety results demonstrate that Susvimo can deliver robust vision outcomes over two years for people with diabetic eye diseases that can cause vision loss,” said Levi Garraway, MD, PhD, chief medical officer, head, global product development, Genentech, in a press release. “If approved by the FDA, Susvimo could bring a new treatment paradigm for diabetic eye diseases. We hope to bring this option to people with diabetic macular edema and diabetic retinopathy as soon as possible to help maintain their vision and potentially their independence.”

Pagoda is a multicenter, randomized, active treatment-controlled, non-inferiority study evaluating the efficacy, safety, and pharmacokinetics of Susvimo 100 mg/mL refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections, in 634 patients with diabetic macular edema. The primary endpoint of the study was a change in best-corrected visual acuity score from baseline at the average of weeks 60 and 64.

Pavilion is a multicenter, randomized study comparing the efficacy, safety, and pharmacokinetics of Susvimo every nine months vs. patients under monthly clinical observation, in 174 individuals with diabetic retinopathy without center-involved diabetic macular edema. The primary endpoint 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.

Results found that 95% of DME patients and 98% of DR patients treated with Susvimo did not require additional injections. In the Pagoda trial, patients continued to maintain improvements in vision gains seen at one year (9.8 eye chart letters). Additionally, no cases of endophthalmitis were reported up to one year and the rate of endophthalmitis through week 112 was 0.7%, compared to 0.8% in the control arm. In the Pavilion trial, 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS from pre-implant baseline at week 100. Further, no cases of endophthalmitis were reported up to one year in this trial as well.

Common adverse events (AEs) included blood on the white of the eye, redness in the white of the eye, sensitivity to light, and eye pain; however, Genentech stated that these aren’t the only AEs that result from Susvimo.

Genentech warns that treatment with Susvimo could lead to an eye infection (endophthalmitis); a missing layer on top of the white part of the eye (conjunctival erosion); an opening of the layer that covers the white part of the eye (conjunctival retraction); tear and separation of layers of the retina (rhegmatogenous retinal detachment); implant movement; implant damage; bleeding; a bump on top of the white layer of the eye (conjunctival bleb); and a temporary decrease in vision. The company also warns that patients should not receive Susvimo if they have an infection around their eye, active eye swelling, or have had an allergic reaction to ranibizumab or any of the ingredients in Susvimo in the past.¹

Reference

New Data for Genentech’s Susvimo Demonstrates Sustained Efficacy in Two Serious Diabetic Eye Conditions. Genentech. July 18, 2024. Accessed July 18, 2024. https://www.gene.com/media/press-releases/15034/2024-07-18/new-data-for-genentechs-susvimo-demonstr