November 4, 2015, Osaka, Japan –– Santen Pharmaceutical Co., Ltd. (Santen) announced today that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending the use of Santen's IKERVIS® (ciclosporin1 mg/mL eye drops emulsion in single-dose containers) in England for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.1
IKERVIS® is the first and only topical preparation licensed for the treatment of severe keratitis in patients with dry eye disease in the UK.2 IKERVIS® has a novel cationic nano-emulsion formulation to effectively deliver the anti-inflammatory potential of ciclosporin3,4. 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.5
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).
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.
This press release is also prepared in other languages. However this English document is the original document, and documents prepared in other languages are for your reference only. In case of any discrepancy between the English and translated versions, the English version will prevail. Please refer to http://www.santen.eu for the original English document.
Corporate Communication Group Santen Pharmaceutical Co., Ltd.
1 NICE advice, published at http://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 Lalleman F et al. J Drug Deliv 2012: 604204
4 Daull P, et al. 2013 Mar; 32 (3): 345-54
5 SMC advice, published at https://www.scottishmedicines.org.uk/SMC_Advice/Advice_Directory/SMC_Advice_Directory [12 October 2015]