2015年3月27日，日本眼科领域领导者参天制药（Santen Pharma）近日宣布，该公司研发的眼科药物Ikervis（ciclosporin，环孢素）获欧盟委员会（EC）批准，用于经人工泪液治疗未得到改善的干眼病成人患者严重角膜炎的治疗。
干眼症（dry eye）又名角结膜干燥症（KCS），是指任何原因造成的泪液质或量异常或动力学异常，导致泪膜稳定性下降，并伴有眼部不适和(或)眼表组织病变特征的多种疾病的总称。它是目前最为常见的眼表疾病，主要治疗方法是使用人工泪液。
目前，干眼病患者严重角膜炎治疗方面，仍存在着真真实实的治疗挑战。而Ikervis的上市，将为欧洲干眼病患者提供首个处方药，同时标志着该地区严重干眼病患者临床治疗的重大进步。
Ikervis的获批，是基于在欧洲开展的一项III期临床项目的数据。该研究在伴有严重角膜炎的干眼病成人患者中开展，调查了ciclosporin的疗效和安全性。根据所提交的质量、安全性和疗效数据，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）在2015年1月建议批准Ikervis。CHMP审查后认为，Ikervis具有很好的效益-风险平衡，建议批准上市，造福欧洲的干眼病患者。
Ikervis的活性药物成分是环孢素（ciclosporin），这是一种免疫抑制剂，归属于眼科类治疗产品。环孢素能够阻断前炎性细胞因子 (pro-inflammatory cytokine)的释放，在眼表细胞发挥抗炎作用。Ikervis的治疗益处是能够改善眼表损伤并减少炎症反应。
New Drugs Online Report for ciclosporin
Information
Generic Name: ciclosporin
Trade Name: Ikervis
Synonym: Nova22007, Cyclokat
Entry Type: New formulation
Development and Regulatory status
UK: Launched
EU: Launched
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date: June 2015
Comments
Jun 15: Launched in UK [9].
20/08/2015 17:11:29
Mar 15: Approved in the EU [7].
30/03/2015 22:24:23
Jan 15: EU positive opinion for treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes [6].
23/01/2015 14:02:22
Dec 13: Filed in the EU for treatment of dry eye disease [5].
23/04/2014 10:27:48
PIII in EU & US [1].
26/02/2013 14:32:40
Trial or other data
Dec 15: NICE published TA 369 and recommends Ikervis as a possible treatment for people with dry eye disease that has not improved despite treatment with artificial tears [11].
22/12/2015 10:26:15
Nov 15: Amended DRAFT NICE guidance recommends ciclosporin (Ikervis) as an option for treating severe keratitis in adult patients with dry eye disease that has not improved despite treatment with tear substitutes [10].
04/12/2015 17:22:31
Jun 15: DRAFT NICE guidance does not recommend ciclosporin eye drops within its marketing authorisation, for treating severe keratitis in adults with dry eye disease, which has not improved despite treatment with tear substitutes. Further analyses is required from the company [8].
25/06/2015 10:36:51
NCT01751126 a multicenter, randomized, double-masked study of NOVA22007 1mg/ml (ciclosporin) eye drops, emulsion administered in 168 paediatric patients with active severe vernal keratoconjunctivitis with severe keratitis. The primary outcome is composite efficacy score over 4 months of treatment base on keratitis and need for rescue medication for two different dosing regimens of NOVA22007 vs placebo. The study started Mar 13 and is due to complete Jul 14 [5].
15/04/2014 14:19:13
May 13: Novagali Pharma changed its name to Santen [3]
15/04/2014 14:13:29
PIII Sansika (EUCTR2011-000160-97-GB) trial is enrolling 252 adults with severe, persistant dry eye syndrome from the EU & US. Pts will be randomised to ciclosporin A 1mg/ml ophthalmic emulsion once daily vs vehicle with no active pharmacological component, once daily, for 6 mths. Primary outcomes are CFS; ocular tolerability; ocular safety. Expected study completion date is Q3/4 2012 [1].
26/02/2013 14:39:29
Sep 07: PIII Siccanove (NCT00814515) trial begins recruiting 482 adults with moderate to severe dry eye condition persisting despite conventional management from sites in France. Pts will be randomised to ciclosporin A (0.1%) ophthalmic emulsion once daily vs vehicle with no active pharmacological component, once daily for 6 mths. The primary outcome is corneal fluorescein staining (CFS) & ocular discomfort; secondary oputcomes are ocular symptom disease index questionnaire & percentage of complete responders (measured using CFS). The trial is expecetd to complete in Sep 09 [2].
26/02/2013 14:37:44
Evidence Based eva luations
SMC http://www.scottishmedicines.org.uk/SMC_Advice/Advice/1089_15_ciclosporin_Ikervis/ciclosporin_Ikervis
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002066/WC500186592.pdf
NICE scope http://www.nice.org.uk/Guidance/InDevelopment/GID-TAG466/Documents
NHSC http://www.nhsc-healthhorizons.org.uk/files/downloads/1849/2236.8a804edb.CiclosporinA_June12.pdf
References
Available only to registered users |
