Santen Pharmaceutical Co., Ltd., a specialized ophthalmology company, has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravitreal (IVT) sirolimus (440 µg), development code DE-109, for the treatment of non-infectious uveitis of the posterior segment (NIU-PS). The FDA has set an action date of December 24, 2017 to complete its review of the IVT sirolimus NDA, per the Prescription Drug User Fee Act (PDUFA). IVT sirolimus was granted orphan drug designation by the FDA and the European Commission (EC) in 2011.

IVT sirolimus, an mTOR inhibitor, is an investigational first-in-class targeted, immunoregulator being developed by Santen for the treatment of patients with NIU-PS. NIU-PS is a progressive and chronic inflammatory disease of the eye that can lead to vision impairment and blindness. The NDA for IVT sirolimus is supported by data from the SAKURA Program, the largest phase III global clinical programme to date evaluating patients with NIU-PS.

“The FDA acceptance of the NDA for IVT sirolimus is an important milestone, and brings us closer to potentially offering a locally-administered treatment option for patients with NIU-PS,” said Naveed Shams, M.D. Ph.D, chief scientific officer and head of global R&D at Santen.