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Santen’s intravitreal sirolimus for noninfectious posterior segment uveitis not approved

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The FDA announced that it is unable to approve Santen Pharmaceutical’s new drug application for intravitreal sirolimus, an investigational treatment for noninfectious posterior segment uveitis, according to a company press release.

A complete response letter to the NDA “requests additional substantiating evidence to demonstrate the efficacy” of intravitreal sirolimus in treating adults with noninfectious uveitis of the posterior segment.

“We are evaluating the FDA’s response and will work closely with the agency to determine the best path forward,” Naveed Shams, MD, PhD, Santen’s chief scientific officer and head of global research and development, said in the release. “We strongly believe in the benefits of [intravitreal] sirolimus for noninfectious uveitis of the posterior segment patients and will continue to work towards our goal of bringing a local, nonsteroidal therapy to patients suffering from this sight-threatening disease.”