New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions

發(fā)布時間： 2024-07-25 閱讀：143次

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July 22, 2024 – Roche announced today 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.

In Pavilion, people with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared with participants under monthly clinical observation. No individuals treated with Susvimo needed additional treatment with supplemental injections during the primary analyses study period (52 weeks), compared to 60% in the control arm.

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. 

Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customised formulation of ranibizumab over time. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.