Roche Susvimo gets USFDA green light for Diabetic Retinopathy
Basel: Roche has received approval from the US Food and Drug Administration (FDA) for Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the US and more than 100 million people globally.
It is an 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 US retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.”
“Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,” said vitreoretinal surgeon, Carl Awh, M.D., Tennessee Retina, Tennessee. “I am delighted to have this far more durable treatment available for my patients.”
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 customised 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.
Accounting for approximately 5% of all cases of visual impairment, diabetic retinopathy (DR) occurs when damage to the blood vessels and the formation of new blood vessels causes blood and/or fluid to leak into the retina - a part of the eye that sends information to the brain, enabling sight. This leads to swelling, as well as blockage of the blood supply to some areas of the retina. As the condition progresses, vision becomes impaired. DR affects approximately 103 million people globally, resulting in blindness in almost five million people.
