Ikervis Ciclosporin available in Scotland, UK.
The Scottish Medicines Consortium has completed its assessment of the use of ciclosporin 1mg/mL (0.1%) and advises NHS boards and Area Drug and Therapeutic Committees on its use in Scotland. (SMC No (1089/15).
Ikervis Ciclosporin is used in the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Dosing information: One drop once daily to be applied to affected eye(s) at bedtime. Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption. This may result in a decrease in systemic undesirable effects and an increase in local activity. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. Ciclosporin eye drops should be administered last.
Response to treatment should be reassessed at least every six months. Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Ciclosporin eye drops are the first ophthalmic formulation of ciclosporin licensed in the UK. For several years treatment of dry eye has included specially compounded ciclosporin eye drops and imported products licensed in other countries, e.g. ciclosporin 0.05% ophthalmic emulsion (Restasis ®), which is administered to the affected eye(s) as one drop twice daily.
The main adverse events with ciclosporin eye drops appear to be related to ocular discomfort when administering the medicine.
Within an ad-hoc expert meeting during the European Medicines Agency (EMA) review it was noted that treatment of dry eye disease should aim to control the underlying disease and in addition to this, available treatments include artificial tears or lubricants for symptoms, with anti-inflammatory preparations for more severe forms of disease, including short-term corticosteroids and topical ciclosporin (compounded or imported). Autologous serum was also considered beneficial. However, it was noted that the medicines currently used in practice do not have a demonstrated effect on clinical signs and many patients continue to suffer impaired function, pain and irritation. There was a consensus that there is an unmet medical need in this disease.
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