FDA Approves Roche's Susvimo For Diabetic Retinopathy

Roche (RHHBY) has received FDA approval for Susvimo to treat diabetic retinopathy (DR), marking its third approved indication. Susvimo, utilizing the Port Delivery Platform, is the first continuous delivery treatment requiring only one refill every nine months for DR patients who previously responded to anti-VEGF injections. The approval is based on the phase III Pavilion study, where patients showed superior improvements on the Diabetic Retinopathy Severity Scale compared to monthly observation with as-needed anti-VEGF injections. The treatment involves a refillable eye implant surgically inserted during an outpatient procedure. DR affects nearly 10 million people in the US and over 100 million globally. Notably, no participants required supplemental treatment at one year, and the safety profile remained consistent with previous findings.

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