Phase III trial of sirolimus for Uveitis meet primary endpoint - Santen

Santen has announced that SAKURA Study 1, the first of two Global Phase III studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment Uveitis (NI-PSU), met its primary endpoint. SAKURA is an ongoing multinational, multicenter, randomized, double-masked study assessing the safety and efficacy of sirolimus. 347 patients with non-infectious posterior, intermediate or panuveitis were enrolled at approximately 150 sites for SAKURA Study 1. Eligible patients were randomized into three treatment arms, each receiving different doses of sirolimus by intravitreal injection. The primary endpoint was the proportion of patients achieving a vitreous haze score of zero at month five (Standardized Uveitis Nomenclature [SUN] Photographic scale). SAKURA Study 2 continues to enroll patients under the same protocol.