Ciclosporin Ophthalmic Emulsion 0.1%: A Review in Dry Eye Disease

Compliance with Ethical Standards

Funding: The preparation of this review was not supported by any external funding.

Conflicts of interest: Sheridan Hoy is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here.

Abstract

Ciclosporin ophthalmic emulsion 0.1% (hereafter referred to as ciclosporin 0.1%) [Ikervis®] is an unpreserved cationic emulsion formulation containing an 0.1% concentration of ciclosporin. It has been approved in various countries worldwide, including those of the EU, for the treatment of severe keratitis in adults with dry eye disease, which has not improved despite treatment with tear substitutes. In a multinational, phase III study in this patient population, once-daily ciclosporin 0.1% was associated with statistically significant and clinically relevant improvements in the signs (corneal surface damage and ocular surface inflammation) of dry eye disease relative to vehicle during the first 6-month treatment period. These beneficial effects were maintained or improved in a subsequent 6-month period, with data suggesting sustainability following treatment discontinuation in a 24-month, phase III extension study. Ciclosporin 0.1% was well tolerated in these studies, with instillation-site pain (which was mostly mild in severity) being the most frequently reported ocular treatment-related adverse event. There were no findings to suggest the systemic absorption of ciclosporin. Thus, once-daily ciclosporin 0.1% is an effective and well tolerated option for the treatment of severe keratitis in adults with dry eye disease. Access to the full article can be found here.

© Springer International Publishing AG, part of Springer Nature 2017