ST ALBANS, England, November 4, 2015 /PRNewswire/ --
The National Institute for Health and Care Excellence (NICE) Issues Positive Recommendation in Final Appraisal Determination (FAD) for IKERVIS® (ciclosporin 1 mg/mL eye drops emulsion in single-dose containers)
NICE has announced today that it has recommended the use of Santen's IKERVIS® (ciclosporin 1 mg/mL eye drops emulsion in single-dose containers) for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.[1]
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This gives patients across England and Wales access to the first and only eye drops licensed for the treatment of severe keratitis in patients with dry eye disease in the UK.[2]
It is estimated that 61,000 adults in England and Wales suffer from the severe form of dry eye disease.[3] Symptoms of dry eye disease include burning, itching and dryness, gritty sensation and photophobia.[4],[5] Severe keratitis is an inflammation of the cornea, the top layer of the eye, which can result from dry eye disease, and can result in permanent damage to the eye if not treated.[6] It is a distressing condition for patients with a very significant impact on well-being and quality of life, and can lead to serious complications, including infection and even loss of sight.[6]
Professor Figueiredo, Professor of Ophthalmology at Newcastle's Royal Victoria Infirmary and Newcastle University, said, "NICE's positive appraisal of Ikervis means that UK patients with severe keratitis and dry eye disease will have access for the first time to a licensed product with the potential to have a significant positive impact. Patients with this particularly unpleasant and disabling condition have a seriously impaired quality of life, and patients often have been unable to access licensed treatment that they need. Ophthalmologists now have a new and licensed treatment option that could make a real difference to our patients"
Mr Craig Wallace, General Manager for Santen UK and Ireland said, "This recommendation by NICE underscores what an important medicine IKERVIS® is for patients with severe dry eye diseases. This is a very proud moment for Santen."
About IKERVIS[®]
Ciclosporin works by reducing inflammation in dry eye disease.[2] However, until the launch of IKERVIS®, there has been no topical preparation of ciclosporin licensed in the UK.[2] In IKERVIS®, the ciclosporin is suspended in a novel emulsion to effectively deliver its anti-inflammatory effect.[7],[8] With this recommendation from NICE, IKERVIS® provides an important new option for the treatment of patients in England who have not responded to tear substitutes. In October of this year the Scottish Medicine's Consortium (SMC) determined that IKERVIS® should be made available to patients in Scotland.[9]
The NICE decision was based on data from the SANSIKA trial.[10] This was a double-masked multicentre, randomised, vehicle-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 dry eye disease. 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.[10]
About Santen
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 (http://www.santen.com).
Santen Forward-looking Statements
Information provided in this press release contains forward-looking statements. The achievement of these forecasts is subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial conditions are subject to the effects of changes in regulations made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.
1. NICE advice, published at https://www.nice.org.uk/guidance/GID-TAG466/documents/final-appraisal-determination-document [accessed 4 November 2015]
2. Ikervis SmPC June 2015, available at https://www.medicines.org.uk/emc/medicine/30584
3. Data on file Santen UK
4. Lemp MA. Am J Ophthalmol. 2008;146(3):350-6.
5. Report of the international dry eye workshop (DEWS). Ocul Surf. 2007;5(2):65-204.)
6. Baudouin C, et al. Br J Ophthalmol 2014;98:1168-1176
7. Lalleman F et al. J Drug Deliv 2012: 604204
8. Daull P, et al. 2013 Mar; 32 (3): 345-54
10. SANSIKA study. Data on file. Santen UK Limited
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