New data for Susvimo (ranibizumab injection) demonstrates sustained efficacy in diabetic macular edema and diabetic retinopathy

Susvimo is the first and only refillable eye implant that provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform.

The results build on the primary one-year analyses of the Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy over two years and safety consistent with the known safety profile for Susvimo in people with DME and DR. Detailed results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.

Additionally, the FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for Susvimo for the treatment of DME and DR. The filing acceptance is based on the one-year results from the Phase III Pagoda and Pavilion studies, which showed that both studies met their primary endpoint. To date, Susvimo is approved in the U.S. for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

“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, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “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.”

One-year primary data supporting U.S. sBLA in DME and DR.: Treatment for DME typically involves regular eye injections every one to four months. In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior visual acuity gains compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections. Approximately 95% of patients treated with Susvimo did not need additional treatment with supplemental injections during the primary analyses study period (64 weeks). In Pavilion, people with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared with participants under monthly clinical observation. No individuals treated with Susvimo needed additional treatment with supplemental injections during the primary analyses study period (52 weeks), compared to 60% in the control arm.

Two-year Pagoda and Pavilion results presented at ASRS: In Pagoda, people with DME receiving Susvimo refilled every six months through approximately two years (112 weeks) continued to maintain improvements in vision gains seen at one year (9.8 eye chart letters). A gain of 9.8 eye chart letters is similar to gaining two more lines on an eye chart. Approximately 95% of individuals did not need additional treatment with supplemental injections. Anatomically, Susvimo showed sustained improvements in central subfield thickness (CST) through week 112. Reduction in CST, a measure of retinal drying, is an indicator of swelling from fluid in the back of the eye caused by unstable, leaky blood vessels. The safety data were consistent with the known safety profile for Susvimo in people with DME, with no new safety signals observed. In people treated with Susvimo, 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. Refills of Susvimo were resumed in affected participants after successful resolution of endophthalmitis.

In Pavilion, people with DR receiving Susvimo refilled every nine months through approximately two years (100 weeks) maintained DRSS improvements seen at one year. Specifically, at week 100, 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS from pre-implant baseline, and participants who received Susvimo from week 64 either maintained or improved their DRSS score from pre-implant baseline. A two-step or greater improvement in the DRSS is a clinically relevant measure of the decrease in risk for developing vision-threatening complications secondary to diabetes. Approximately 98% of participants treated with Susvimo did not need additional treatment with supplemental injections. The safety data were consistent with the known safety profile for Susvimo in people with DR, with no new safety signals observed. In people treated with Susvimo, no cases of endophthalmitis were reported up to one year and the rate of endophthalmitis through week 100 was 0.8%. One participant with DR developed endophthalmitis and continued receiving treatment with Susvimo refills after successful resolution.

About the Pagoda Study: Pagoda (NCT04108156) is a multicenter, randomized, active treatment-controlled, non-inferiority U.S.-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo (ranibizumab injection) 100 mg/mL refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections, in 634 people with diabetic macular edema. Participants were randomized 3:2 to receive either Susvimo refilled every six months or continued monthly intravitreal ranibizumab injections. In the Susvimo arm, participants received four loading doses of intravitreal ranibizumab before Susvimo implantation at week 16. The primary endpoint of the study is a change in best-corrected visual acuity score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of week 60 and week 64. Following primary analysis, participants who were initially randomized to intravitreal injections received Susvimo, with refills every 24 weeks.

About the Pavilion Study: Pavilion (NCT04503551) is a multicenter, randomized, U.S.-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo (ranibizumab injection) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with diabetic retinopathy without center-involved diabetic macular edema. Participants were randomized 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. 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. Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64.