Santen Inc., the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co., Ltd. (Osaka, Japan), today announced that SAKURA (Study Assessing double‐masKed Uveitis tReAtment) 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.
"NI-PSU is a debilitating disease which affects working-aged adults worldwide. Currently, there are no FDA approved non-steroidal treatments for this sight threatening condition. We are excited by the SAKURA data and believe sirolimus may provide physicians with the first non-steroidal intravitreal treatment option for their patients suffering with NI-PSU," said Dr. Naveed Shams, Chief Scientific Officer and President & CEO of Santen Inc.
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.
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