Santen announced results from its Phase 3 trial evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU).

SAKURA (Study Assessing double‐masKed Uveitis tReAtment) Study 1 is the first of two Global Phase 3 studies assessing the safety and efficacy of sirolimus. It is an ongoing multinational, multicenter, randomized, double-masked study which enrolled patients (n=347) with non-infectious posterior, intermediate or panuveitis. Eligible patients were randomized into three treatment arms, each receiving different doses of sirolimus by intravitreal injection. SAKURA Study 2 continues to enroll patients under the same protocol.

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The primary endpoint in this study was met with a proportion of patients achieving a vitreous haze score of zero at month five (Standardized Uveitis Nomenclature [SUN] Photographic scale).

Sirolimus is a mTOR inhibitor that is the same active pharmaceutical ingredient found in two FDA approved products, Rapamune and CYPHER. Rapamune is approved for organ rejection prophylaxis in renal transplant patients in combination with cyclosporine and corticosteroids. CYPHER (Sirolimus-eluting Coronary Stent) is approved for improving coronary luminal diameter in patients with symptomatic ischemic disease. Intravitreal sirolimus is a proprietary ocular formulation of sirolimus.

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