Eyes on Santen: FDA accepts NDA for intravitreal sirolimus

Santen Pharmaceuticals has announced that the FDA has accepted the new drug application (NDA) for intravitreal (IVT) sirolimus for the treatment of non-infectious uveitis of the posterior segment (NIU-PS).

An action date of 24 December has been set for the completion of the FDA’s review of the NDA. IVT sirolimus was granted orphan drug designation by the administration and the European Commission (EC) in 2011.

“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 Dr Naveed Shams, PhD, chief scientific officer and head of global R&D at Santen.

IVT sirolimus is an mTOR inhibitor and is under development by Santen as an investigational targeted immunoregulator for the treatment of patients with NIU-PS. It works by inhibiting the protein kinase, mTOR, which plays a key role in inflammation. NIU-PS is a progressive and chronic inflammatory disease of the eye that can lead to vision impairment and blindness.

The NDA has been supported by a Phase III global clinical programme, the SAKURA Program, that is evaluating patients with NUI-PPS.

Santen is a speciality pharmaceutical company that focuses on the ophthalmic field. It performs research, development, market and sales of pharmaceuticals and devices and is based in Japan.