CHMP recommends Ikervis (cyclosporine ophthalmic emulsion) for treatment of keratitis in Dry Eye Disease-Santen
Santen Pharmaceutical Co., Ltd. announced that Santen S.A.S., its subsidiary in France, received a positive opinion recommending the granting of a marketing authorization for Ikervis (cyclosporine ophthalmic emulsion), from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 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, which blocks the release of proinflammatory 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.
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