March 25, 2015
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Santen obtains European Commission approval to market Ikervis
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Santen Pharmaceutical received approval from the European Commission for a marketing authorization application for Ikervis, according to a press release.
Ikervis (cyclosporine) is approved to treat severe keratitis in adults with dry eye disease who have not improved with tear substitute treatment.
The approval was based on a phase 3 clinical program of the safety and efficacy of cyclosporine in European patients, for which Ikervis received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in January, the release said.
Ikervis is the first prescription treatment in Europe for dry eye disease patients with severe keratitis.