By Fineline Cube 
Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its Susvimo (ranibizumab) 100mg/mL intravitreal ocular implant has received another indication approval from the US Food and Drug Administration (FDA). The approval extends Susvimo’s use to treat patients with diabetic retinopathy (DR) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. This marks a further expansion of Susvimo’s therapeutic applications following previous approvals for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Susvimo Mechanism and Delivery
Susvimo is a refillable eye implant surgically inserted into the eye. It provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, requiring just one refill every nine months. This innovative delivery method ensures sustained treatment with minimal patient burden.
Clinical Trial Results
The FDA approval is based on results from the Phase III Pavilion study. The study demonstrated that patients with DR who received Susvimo refills every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety results were consistent with the known profile of Susvimo.-Fineline Info & Tech