Santen files Opsiria ( intravitreal sirolimus) at EMA to treat noninfectious uveitis.

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 blindness.

The EMA submission is supported by data from SAKURA (Study Assessing double?masKed Uveitis tReAtment), a pivotal Phase III study. 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.