Santen receives a positive CHMP opinion for EU marketing authorization for Ikervis®

Santen SAS, (Evry, France) (Santen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Ikervis®.  

Santen submitted a Marketing Authorization Application (MAA) under the centralized procedure for Ikervis® in December 2013. The CHMP based its positive opinion on its review of the comprehensive data package for Ikervis®. Ikervis® was granted a positive opinion for the “treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes”.  

The active substance of Ikervis is ciclosporin, an immunosuppressant, belonging to the therapeutic class of ophthalmologicals. Ciclosporin blocks the release of pro-inflammatory cytokines and exerts an anti-inflammatory effect in ocular surface cells. The benefits with Ikervis are its ability to improve ocular surface damage and reduce inflammation in dry eye disease patients with severe keratitis.