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FDA grants NDA for intravitreal sirolimus for non-infectious uveitis of posterior segment

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The FDA has accepted a new drug application for intravitreal sirolimus for the treatment of non-infectious uveitis of the posterior segment, Santen announced in a press release.

An action date of Dec. 24 has been set for the completion of the NDA review, according to the release.

Both the FDA and the European Commission granted the mTOR inhibitor orphan drug designation in 2011.

“The FDA acceptance of the NDA for [intravitreal] sirolimus is an important milestone and brings us closer to potentially offering a locally administered treatment option for patients with [non-infectious uveitis of the posterior segment],” Naveed Shams, MD, PhD, Santen’s chief scientific officer and head of global R&D, said in the release.