Roche announced the two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® (Port Delivery System with ranibizumab) for New Data Highlights Susvimo’s Potential for treating Diabetic Eye Conditions such as diabetic macular edema (DME) and diabetic retinopathy (DR). The data indicates Susvimo’s sustained efficacy and consistent safety profile in managing these two leading causes of vision loss in adults with diabetes. Susvimo is the first and only refillable eye implant that provides continuous delivery of ranibizumab via the Port Delivery Platform, presenting a promising alternative to regular eye injections. Detailed results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
The United States Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) for Susvimo based on one-year results from the Phase III Pagoda and Pavilion studies. In the Pagoda study, patients 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 the Pavilion study, patients with DR who received Susvimo refilled every nine months showed superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to participants under monthly clinical observation.
Two-Year Data and Safety Profile
In Pagoda, patients 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. 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, indicating reduced swelling from fluid in the back of the eye. The safety data were consistent with Susvimo’s known safety profile for DME, with no new safety signals observed.
In Pavilion, patients with DR receiving Susvimo refilled every nine months maintained DRSS improvements seen at one year. At week 100, 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS from pre-implant baseline. Approximately 98% of participants treated with Susvimo did not need additional treatment with supplemental injections, with the safety data remaining consistent.
Potential Impact on Diabetic Eye Disease Treatment
“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., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
Diabetic macular edema (DME) is a vision-threatening retinal condition that occurs when damaged blood vessels leak into and cause swelling in the macula, the central area of the retina responsible for sharp vision. Approximately 29 million people globally are affected by DME, and the number is expected to grow as the prevalence of diabetes increases. Diabetic retinopathy (DR), which accounts for about 5% of all cases of visual impairment, occurs when damage to the blood vessels and the formation of new blood vessels cause blood or fluid to leak into the retina. DR affects approximately 103 million people globally, resulting in blindness in almost five million people.
Roche’s Commitment to Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. The company has the broadest retina pipeline in ophthalmology, informed by insights from people with eye diseases. Roche’s innovation spans scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers, and continuous drug delivery. The company strives to design the right therapies for the right patients, aiming to bring breakthrough ophthalmic treatments to people living with vision loss.
Roche’s pipeline includes an innovative cell therapy and treatments across multiple vision-threatening conditions, such as geographic atrophy and autoimmune conditions like thyroid eye disease and uveitic macular edema. Susvimo® (Port Delivery System with ranibizumab) for intravitreal use via ocular implant is the first FDA-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration (nAMD). Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, targeting and inhibiting two signalling pathways linked to vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.
Founded in 1896 in Basel, Switzerland, Roche has grown into the world’s largest biotechnology company and a global leader in in-vitro diagnostics. The company is dedicated to scientific excellence and personalised healthcare, aiming to transform healthcare delivery. Roche combines strengths in Diagnostics and Pharma with data insights from clinical practice to provide the best care for each person. Recognised as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices for fifteen consecutive years, Roche continues to improve access to healthcare worldwide.
Resource: Roche, July 18, 2024
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