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Emerging two-year data from a pair of Phase III studies—Pagoda (NCT04108156) and Pavilion (NCT04503551)—evaluating Roche’s Susvimo (Port Delivery System with ranibizumab) for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR) demonstrate sustained efficacy and safety consistent with the known safety profile for Susvimo in people with DME and DR.1
Additionally, the FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for Susvimo for the treatment of DME and DR. The acceptance is based on prior one-year results from the previously mentioned Phase III studies.
According to Roche, 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 Pagoda Phase III trial is a multicenter, randomized, visual assessor-masked, active-comparator study.2 It evaluated Susvimo refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections in 634 participants with DME. The primary endpoint 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.
Among the two-year results from Pagoda, participants continued to maintain improvements in vision gains seen at one year (9.8 eye chart letters). Approximately 95% of individuals did not need additional treatment with supplemental injections.
Meanwhile, the Pavilion Phase III study is a multicenter, randomized trial in participants with DR without center-involved DME.3 It also evaluated Susvimo, but at 100 mg/mL refilled every nine months compared with those under monthly clinical observation, in 174 participants. 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 (DRSS) at week 52.
Two-year results from Pavilion showed 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.
“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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development said in a press release. “If approved by the US 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.”
Susvimo is currently approved in the US for the treatment of neovascular or ‘wet’ age-related macular degeneration.
References
1. New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions. News release. Roche. July 18, 2024. Accessed July 18, 2024. https://www.roche.com/media/releases/med-cor-2024-07-18
2. This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab (Pagoda). ClinicalTrials.gov. Accessed July 18, 2024. 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. Accessed July 18, 2024. https://clinicaltrials.gov/study/NCT04503551