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On 22 January 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ikervis, 1 mg/ml, eye drops intended for the treatment of severe keratitis in adult patients with dry eye disease (DED). The applicant for this medicinal product is Santen SAS. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Ikervis is ciclosporin, an immunosuppressant belonging to the therapeutic class of ophtalmologicals (S01XA18). 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 DED patients with severe keratitis, which is thought to help prevent disease progression and worsening. The most common side effects are eye pain (19%), eye irritation (17.8%), lacrimation (6.2%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%).

A pharmacovigilance plan for Ikervis will be implemented as part of the marketing authorisation.

The approved indication is:

"Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1)".

Ikervis treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Ikervis and therefore recommends the granting of the marketing authorisation.

Name Language First published Last updated
CHMP summary of positive opinion for Ikervis (English only) 2015-01-23  

Key facts

Product details for Ikervis
INN or common name


Therapeutic area Corneal Diseases
Active substance


Date opinion adopted22/01/2015
Company name

Santen SAS

Application typeInitial authorisation