Breakthrough in diabetes care: Roche’s Susvimo could revolutionize eye treatment

Roche, a global leader in pharmaceuticals and diagnostics, recently unveiled two-year data from the pivotal Phase III Pagoda and Pavilion studies, showcasing the sustained efficacy and safety of Susvimo in treating two critical diabetic eye conditions: diabetic macular edema (DME) and diabetic retinopathy (DR). These conditions are among the leading causes of vision loss in adults with diabetes.

Susvimo, a refillable eye implant developed by Roche, offers a novel approach by providing continuous delivery of a customized formulation of ranibizumab directly to the eye through its Port Delivery Platform. This first-of-its-kind technology aims to maintain therapeutic levels of medication without the need for frequent injections.

The two-year outcomes of the Pagoda and Pavilion studies revealed that Susvimo effectively maintains vision improvements and demonstrates a safety profile consistent with previous findings. These results were recently presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.

– Pagoda Study: In patients with DME, those treated with Susvimo refilled every six months experienced substantial and sustained improvements in vision, quantified as a 9.8-letter gain on an eye chart over approximately two years. Moreover, about 95% of these patients did not require any additional treatment with supplemental injections.

– Pavilion Study: For DR patients, Susvimo refilled every nine months led to significant improvements in the Diabetic Retinopathy Severity Scale (DRSS), with 80% of participants achieving a two-step or greater improvement by the end of two years.

Following the compelling one-year results, the U.S. Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) for the expanded use of Susvimo to treat DME and DR. Currently approved in the U.S. for neovascular or ‘wet’ age-related macular degeneration (nAMD), this acceptance marks a significant step towards broadening its application to diabetic eye diseases.

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, expressed optimism about the trial’s impact: “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. If approved by the US FDA, Susvimo could bring a new treatment paradigm for diabetic eye diseases.”

Roche continues to lead the way in developing treatments for eye diseases with the broadest retina pipeline in ophthalmology. The introduction of Susvimo aligns with Roche’s ongoing commitment to innovative therapies that improve the lives of those suffering from serious health issues, including vision loss due to diabetes.