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news.Roche’s Genentech has gained the US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR).
The injection will be available for diabetic retinopathy patients who have shown a response to a minimum of two prior anti-VEGF injections. Credit: Towfiqu barbhuiya on Unsplash.
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This decision marks the injection as the first and only approved continuous delivery treatment by the FDA capable of maintaining vision in DR patients, with a refill required only every nine months.
Intended for intravitreal use through an ocular implant, Susvimo is available for use by retina specialists in the country now with this approval.
It will be available for DR patients who have shown a positive response to a minimum of two prior anti-vascular endothelial growth factor (VEGF) injections.
The agency’s approval is supported by the Phase III Pavilion study’s one-year outcomes, demonstrating that those receiving the injection’s refills every nine months experienced significant improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to those receiving monthly clinical observation and as-needed anti-VEGF injections.
According to the study, Susvimo-treated subjects showed a decrease in the eye damage severity due to diabetes.
Notably, none of the subjects needed supplemental treatment within the first year.
The safety profile of the injection was found to be consistent with previously known data, further supporting its use as a viable treatment option for those suffering from this potentially blinding condition.
Genentech noted that the injection offers continuous delivery of customised ranibizumab formulation through the Port Delivery Platform, which is a refillable eye implant inserted in the eye surgically, in an outpatient procedure.
Roche Global Product Development head and chief medical officer Levi Garraway said: “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.
“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.”
