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

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.

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Acknowledgments

During the peer review process, the manufacturer of ciclosporin ophthalmic emulsion 0.1% was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Sheridan M. Hoy.

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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 at http://www.medengine.com/Redeem/780CF06039AC338F.

Additional information

The manuscript was reviewed by: S. Bonini, Department of Ophthalmology, University Campus Bio-Medico of Rome, Rome, Italy; A. Leonardi, Ophthalmology Unit, Department of Neuroscience, University of Padua, Padua, Italy; M. Sainz de la Maza, Clinical Institute of Ophthalmology, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain; J. S. Wolffsohn, Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, UK.

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Hoy, S.M. Ciclosporin Ophthalmic Emulsion 0.1%: A Review in Severe Dry Eye Disease. Drugs 77, 1909–1916 (2017). https://doi.org/10.1007/s40265-017-0834-x

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  • DOI: https://doi.org/10.1007/s40265-017-0834-x