EMA accepts Santen’s Marketing Application filing for intravitreal sirolimus for the treatment of noninfectious uveitis of the posterior segment

Santen Pharmaceutical Co., Ltd. announced that the European Medicines Agency (EMA) has accepted the company’s Marketing Authorization Application (MAA) filing for the use of intravitreal sirolimus, an investigational mTOR inhibitor, for the treatment of noninfectious uveitis (NIU) of the posterior segment. The MAA filing marks the beginning of a regulatory review process for intravitreal sirolimus, which has the potential to address an unmet need in the European Union (EU) where NIU of the posterior segment is a leading cause of blindness¹.

“Given the risks associated with currently available therapeutic options for NIU of the posterior segment, a chronic inflammatory condition in many cases, there is a significant need for novel treatments that could be used in a sustained manner to optimize clinical outcomes,” says Dr. Naveed Shams, Chief Scientific Officer and Head, Global R&D, Santen Ltd. “If approved, intravitreal sirolimus would represent a significant step forward in the management of NIU of the posterior segment of the eye.”

The EMA submission is supported by data from SAKURA (Study Assessing double‐masKed Uveitis tReAtment), a pivotal Phase 3 study. The submission seeks approval to market the sirolimus, 440 ug dose for the chronic treatment of NIU of the posterior segment of the eye. Key outcomes supporting the indication include data on proportion of subjects achieving a vitreous haze score of 0 at Month 5, proportion of subjects achieving a vitreous haze score of 0 or 0.5+ at month 5, the proportion of subjects achieving an improvement in vitreous haze score of 2 units, and proportion of subjects successfully tapering-off systemic corticosteroids at Month 5.

1. Wakefield D, Chang JH. Epidemiology of uveitis. Int Ophthalmol Clin. 2005;45(2):1-13.