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NICE nearing green light for dry eye disease treatment

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Draft proposals have been issued backing a treatment for severe keratitis in adults with dry eye disease, which has not improved despite treatment with artificial tears.

The National Institute for Health and Care Excellence has published final draft guidance recommending ciclosporin (Ikervis).

Ciclosporin, manufactured by Santen Pharmaceutical, helps patients increase their eyes’ natural ability to produce tears. It also reduces inflammation in the eye. 

“We are pleased to be able to recommend ciclosporin for adults with severe dry eye disease in final draft guidance”

Carole Longson

The recommendation in the final appraisal determination represents a turnaround from previous versions.

In earlier versions of the guidance, NICE said it was minded not to recommend ciclosporin for dry eye disease, due to a lack of evidence on its clinical and cost-effectiveness compared with established treatments – corticosteroids and artificial tears. 

However, it was subsequently highlighted that other ciclosporin formulations were also being used in clinical practice and NICE decided it was reasonable to assume that they would show similar efficacy to each other.

As a result, in the final draft, NICE has changed its position and concluded that, on balance, ciclosporin is a cost-effective use of NHS resources for people with severe keratitis in adult patients with dry eye disease.

Barring any further changes, final guidance recommending the drug for use by the NHS in England and Wales is expected to be published in December 2015. 

Last month, the Scottish Medicines Consortium has issued guidance accepting the treatment for use within NHS Scotland.

Professor Carole Longson, director of NICE’s Centre for Health Technology Evaluation, said: “The company responded to the requests in the draft guidance for more information, and we are pleased, therefore, to be able to recommend ciclosporin for adults with severe dry eye disease in final draft guidance. 

“I am sure this will be welcome news to patients and healthcare professionals alike,” she added.

The product is a sterile, positively charged, oil-in water, unpreserved ophthalmic emulsion that contains ciclosporin.

“I am sure this will be welcome news to patients and healthcare professionals alike”

Carole Longson

Ciclosporin has an anti-inflammatory effect on the cornea and the lacrimal gland. Following administration, it blocks the expression of pro inflammatory cytokines and subsequently enters corneal and conjunctival infiltrated T-cells, activating them.

Its formulation contains an excipient, cetalkonium chloride, which acts as a cationic agent and is specifically designed to prolong the time each eye drop stays on the epithelial layer of the eye.

Ciclosporin is administered as an eye drop of 1mg/ml once daily at bed time and the cost of a monthly course is £72 (excluding VAT).

Dry eye disease is chronic inflammation of the eyes caused by reduced tear production or excessive tear evaporation.

It can be triggered by a number of factors, including dry or air-conditioned environments, auto-immune diseases, and the adverse effects of some medications.

Symptoms include irritation and redness in the eyes, blurred vision, and a sensation of grittiness or a foreign body in the eye. If left untreated, it can result in blindness in severe cases.

It can affect people of any age, but it is more prevalent in women and in older people, with 15-33% of people aged 65 years or over thought to have dry eye disease.

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