Santen Announces Approval of Ikervis for EU Marketing Authorisation

Santen Pharmaceutical has announced it received approval of the Marketing Authorisation Application (MAA) for Ikervis 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 in January, 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.

Ikervis offers dry eye disease patients with keratitis the first prescription treatment in Europe

Professor Andrea Leonardi, University of Padua, Italy, added: “Treatment of severe keratitis in dry eye patients so far represented a real therapeutic challenge and the availability of Ikervis in Europe will represent a significant progress in the management of severe dry eye patients.”

Masamichi Sato, Head of Santen Europe and President of Santen Holdings EU BV, concluded: “We are delighted with today’s MAA approval that offers dry eye disease patients with severe keratitis the first prescription treatment in Europe. Our commitment is to continue to deliver new treatments for people suffering from dry eye. Ikervis is a tangible result of Santen’s patient-centered approach to innovation.”

For more information about Sante Pharmaceutical Co., Ltd., please visit www.santen.com.