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04 November 2015

NICE gives green light to dry eye disease treatment in final draft guidance

NICE has published final draft guidance recommending ciclosporin (also known as Ikervis, manufactured by Santen Pharmaceutical) for treating severe keratitis1 in adults with dry eye disease which has not improved despite treatment with artificial tears.

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 (such as rheumatoid arthritis, and lupus), 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.

Ciclosporin helps patients increase their eyes' natural ability to produce tears. It also reduces inflammation in the eye. 

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "Severe dry eye disease is painful and can have a significant negative effect on day-to-day life for people with the condition. The company responded to the requests in the draft guidance for more information, and we are pleased, therefore, to be able to recommend ciclosporin for adults with severe dry eye disease in final draft guidance.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."

The final draft guidance (final appraisal determination / FAD) can be found from 00:01hrs on Wednesday 4 November at:

NICE has not yet issued final guidance to the NHS; these decisions may change in the event of an appeal. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is expected to be published in December 2015. 

About the final draft guidance

  1. At draft guidance stage (appraisal consultation document / ACD), NICE was minded not to recommend ciclosporin for dry eye disease, and asked the company for more information.   Although the company responded to all the Committee’s requests, it was not presented with evidence on the relative clinical and cost effectiveness of ciclosporin compared with established clinical practice (corticosteroids [if needed] and artificial tears).       This is because, in response to the Committee’s request, the company presented an updated systematic review and showed that it was not possible to conduct a robust indirect treatment comparison with established clinical practice. The Evidence Review Group (ERG, which is tasked with critically appraising the evidence submissions) agreed with the company. However, the experts highlighted that other ciclosporin formulations are also being used in clinical practice and the Committee agreed that it was important to consider ciclosporin (Ikervis) in comparison with the other ciclosporin formulations. The Committee considered that it was      reasonable to assume that the different ciclosporin formulations would show similar efficacy to each other. Based on analyses presented by the company and the ERG, the Committee considered that the cost of ciclosporin (Ikervis) was reasonable compared with the other ciclosporin formulations and concluded that, on balance, ciclosporin (Ikervis) was a cost-effective use of NHS resources for people with severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with artificial tears.
  2. Ciclosporin (Ikervis, Santen Pharmaceutical) is a sterile, positively charged, oil-in water, unpreserved ophthalmic emulsion that contains ciclosporin (CsA).  Its formulation contains an excipient, cetalkonium chloride, which acts as a cationic agent and is specifically designed to prolong the time each eyedrop stays on the epithelial layer of the eye. Ciclosporin has an anti-inflammatory effect on the cornea and the lacrimal (tear) gland.  Following administration, ciclosporin blocks the expression of pro inflammatory cytokines and subsequently enters corneal and conjunctival infiltrated T-cells, activating them. It has a marketing authorisation in the UK for treating ‘severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes’.   Ciclosporin is administered as an eye drop of 1 mg/ml once daily at bed time.
  3. The acquisition cost of a monthly course of ciclosporin is £72 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.
  4. Following a full submission, the Scottish Medicines Consortium has accepted  Ciclosporin (Ikervis, Santen Pharmaceutical) for use within NHS Scotland.
  5. Dry eye disease can affect people of any age, but it is more prevalent in women and in older people. It is reported that 15 to 33% of people aged 65 years or over have dry eye disease. This is likely to be an underestimate of the true prevalence as people with mild symptoms may not report the condition to their doctor. Approximately 20% of people with dry eye disease have severe disease. (NICE scope on ciclosporin for treating dry eye disease
  6. There is no cure for dry eye disease. Management aims to relieve discomfort and prevent damage
  7. NICE guidelines apply in England, and may be disseminated after local review in Northern Ireland, Wales, and Scotland.


  1. Keratitis is inflammation of the cornea, the front part of the eye.

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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.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE.