Roche announced today two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® (Port Delivery System with ranibizumab) for treating diabetic macular edema (DME) and diabetic retinopathy (DR), the leading causes of vision loss in adults with diabetes. Susvimo is the first refillable eye implant delivering continuous ranibizumab. The results show sustained efficacy over two years, with a safety profile consistent with previous data. These results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
The US FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for Susvimo for DME and DR, based on one-year results from the Pagoda and Pavilion studies, which met their primary endpoints. Susvimo is currently approved in the US for treating neovascular or ‘wet’ age-related macular degeneration (nAMD).
“These results show 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., Roche’s Chief Medical Officer and Head of Global Product Development. “If approved by the FDA, Susvimo could offer a new treatment paradigm for diabetic eye diseases. We aim to bring this option to people with DME and DR as soon as possible to help maintain their vision and independence.”
In the Pagoda study, people with DME who received Susvimo refilled every six months achieved non-inferior visual acuity gains compared with those receiving monthly ranibizumab injections. About 95% of patients treated with Susvimo did not need additional treatment during the primary analyses period (64 weeks). In the Pavilion study, people with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared with those under monthly clinical observation. No participants treated with Susvimo needed additional treatment during the primary analyses period (52 weeks), compared to 60% in the control group.
Two-year data from Pagoda showed that people with DME receiving Susvimo maintained vision gains seen at one year. About 95% did not need additional treatment with supplemental injections, and the safety data remained consistent. In Pavilion, people with DR maintained DRSS improvements seen at one year, with about 98% not needing additional treatment. The safety data for Susvimo were consistent with its known profile, with no new safety signals observed.
Roche is committed to pioneering therapies to save people’s eyesight and has the broadest retina pipeline in ophthalmology, guided by scientific insights and patient needs.
About Diabetic Macular Edema (DME)
DME affects around 29 million people globally and occurs when damaged blood vessels leak into the macula, causing swelling and vision loss. The prevalence of DME is expected to grow with the increasing prevalence of diabetes.
About Diabetic Retinopathy (DR)
DR accounts for about 5% of all visual impairment cases and occurs when damaged blood vessels leak into the retina, leading to swelling and vision impairment. DR affects approximately 103 million people globally, causing blindness in nearly five million.
About the Pagoda Study
Pagoda is a Phase III study evaluating Susvimo refilled every six months compared with monthly ranibizumab injections in 634 people with DME. The primary endpoint is a change in best-corrected visual acuity from baseline at the average of weeks 60 and 64.
About the Pavilion Study
Pavilion is a Phase III study evaluating Susvimo refilled every nine months compared with monthly clinical observation in 174 people with DR. The primary endpoint is the proportion of participants with at least a two-step improvement on the DRSS at week 52.
About Susvimo® (Port Delivery System with ranibizumab)
Susvimo is a refillable eye implant that delivers a customized formulation of ranibizumab over time. Ranibizumab is a VEGF inhibitor designed to inhibit VEGF-A, a protein involved in the formation and leakiness of blood vessels. The formulation delivered by Susvimo is different from the ranibizumab injection marketed as Lucentis®.
About Roche in Ophthalmology
Roche aims to save people’s eyesight through pioneering therapies and has the broadest retina pipeline in ophthalmology. Their pipeline includes innovative treatments for multiple vision-threatening conditions, including diabetic eye diseases, geographic atrophy, and autoimmune conditions. Roche has already introduced breakthrough ophthalmic treatments like Susvimo and Vabysmo® (faricimab) and continues to strive for advancements in vision care.
