St Albans, UK – 12 October 2015 (US-EST) – Santen UK Limited (Santen) announce Advice published today by the Scottish Medicines Consortium (SMC) accepts IKERVIS® (ciclosporin 1 mg/mL eye drops emulsion in single-dose containers) within NHS Scotland for the treatment of severe keratitis in adult patients with dry eye disease (DED), which has not improved despite treatment with tear substitutes1
IKERVIS® is the first and only unpreserved cationic emulsion licensed as topical emulsion in the UK.2 The SMC is the first Health Technology group in the UK to publish advice on the use of IKERVIS®.
The decision was based on data from the SANSIKA trial. This was a double masked multicentre, randomised, controlled six month pivotal phase III trial with a six month open label treatment safety follow up period, which evaluated the efficacy and safety of IKERVIS®, administered once daily in adult patients with severe DED. Key evidence from SANSIKA showed that Ikervis with once-daily dosing, reduces ocular surface inflammation and reduces corneal damage, and is consistent with an improvement in patients' disease severity.3
Severe keratitis is an inflammation of the cornea, which can result from dry eye disease.
It is a distressing condition for patients and has a very significant impact on their well-being and quality of life. Severe keratitis in patients with dry eye disease presents another major challenge: patients may present with signs of serious ocular surface damage but their symptoms may not correlate to the clinical signs, making diagnosis difficult4. However, inflammation if left untreated can lead to further complications, permanent corneal damage and even loss of sight.4
Ciclosporin has an anti-inflammatory effect in dry eye disease. However, until the launch of IKERVIS®, there has been no topical preparation of ciclosporin licensed in the UK for the treatment of severe keratitis in patients with dry eye disease.2 With the SMC acceptance, IKERVIS® provides an important new option for the treatment of these patients.
Mr Sathish Srinivasan, Consultant Ophthalmologist at Ayr and Crosshouse Hospital, Ayrshire and Arran NHS said, "Dry eye disease is associated with a measurable adverse impact on several common and important tasks of daily living, implicating this condition as an important public health problem deserving increased attention and resources. With the approval of IKERVIS® (ciclosporin 1 mg/mL eye drops emulsion in single-dose containers) for use in Scotland, patients with severe dry eye can benefit from this treatment. To have a licensed option gives us prescribers the opportunity to offer more for patients who, until now, had no approved therapy and may have undergone long periods of various frustrating treatments."
Mr Craig Wallace, General Manager for Santen UK and Ireland said, "The acceptance of IKERVIS® by the SMC is great news for patients with severe keratitis. At Santen, we are committed to providing ophthalmologists with innovative products for unmet medical needs. We're proud to be the first manufacturer to provide licensed ciclosporin eye drops to patients in the UK."
SMC advice, published at https://www.scottishmedicines.org.uk/SMC_Advice/Advice_Directory/SMC_Advice_Directory, accessed 12 October 2015
Ikervis SmPC June 2015, available at https://www.medicines.org.uk/emc/medicine/30584
SANSIKA study, Data on file Santen UK Limited
Baudouin C, et al. Br J Ophthalmol 2014;98:1168–1176
As a specialty company dedicated to the ophthalmic field, Santen carries out research, development, sales, and marketing of pharmaceuticals. Santen is the market leader in Japan for prescription ophthalmic pharmaceuticals and sells products in over 50 countries. As a leading company in the field of ophthalmology, Santen aims to contribute to society by supplying valuable products and services to satisfy unmet medical needs. For more details, please see Santen's website (www.santen.com).
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