European Commission approves Santen Pharma's Ikervis for eye disease

Japanese drugmaker Santen Pharmaceutical (TYO: 4536) has received approval of the Marketing Authorization Application for Ikervis (ciclosporin) from the European Commission.

Ikervis is approved for treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. The MAA approval was supported by a Phase III clinical program investigating the efficacy and safety of ciclosporin in European dry eye disease patients with severe keratitis.

Based on quality, safety and efficacy data submitted, Ikervis had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (The Pharma Letter January 23, 2015). The CHMP considered that there was a favorable benefit-to-risk balance for Ikervis and therefore recommended the granting of the marketing authorization. Ikervis is the first drug for the treatment of severe keratitis in adult patients with dry eye disease in Europe.