By: IPP Bureau
Last updated : July 22, 2024 7:52 pm
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Roche announced two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo (Port Delivery System with ranibizumab) for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively, the two leading causes of vision loss in adults with diabetes.
Susvimo is the first and only refillable eye implant that provides continuous delivery of a customised 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 United States (US) Food and Drug Administration (FDA) has accepted Roche’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. o date, Susvimo is approved in the US for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD).
“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.”