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Phase 3 study of sirolimus for posterior segment uveitis achieves primary endpoint

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Santen Inc. announced that its first of two global phase 3 studies analyzing the efficacy and safety of intravitreal injections of sirolimus in noninfectious posterior segment uveitis patients has met its primary endpoint.

The Study Assessing Double‐Masked Uveitis Treatment (SAKURA), achieved a predetermined number of patients with a vitreous haze score of zero at 5 months, according to the release.

Naveed Shams, MD, PhD, chief scientific officer, president and CEO of Santen Inc., said in the release, "We are excited by the SAKURA data and believe sirolimus may provide physicians with the first nonsteroidal intravitreal treatment option for their patients suffering with noninfectious posterior segment uveitis.”

SAKURA is a multinational, multicenter, randomized, double-masked study, as detailed in the release. Study 1 accepted 347 patients with noninfectious posterior, intermediate or panuveitis, with patients receiving different doses of sirolimus, a mTOR inhibitor. Study 2 is currently enrolling similar patients.