FDA Approves Genentech’s Susvimo for Diabetic Retinopathy
Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months. Susvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US
Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR). It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
The FDA decision was based on positive one-year results from the Phase III Pavilion study. People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). This means there was a reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression. Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo.
Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss.
About the Pavilion Study
Pavilion (NCT04503551) is a multicenter, randomized, U.S.-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo® (ranibizumab injection) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with diabetic retinopathy without center-involved diabetic macular edema. Participants were randomized 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52. Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64.
About Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant
Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. 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. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S.
The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis® (ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Genentech is also developing DutaFabs – the next generation of bispecific antibodies designed for increased efficacy and durability – tailored for continuous delivery via the Port Delivery implant.
Source: Genentech