Deuter C M E
Department für Augenheilkunde, Universitätsklinikum Tübingen, Schleichstrasse 12-16, 72076, Tübingen, Germany.
Ophthalmologe. 2010 Jul;107(7):672-5. doi: 10.1007/s00347-010-2217-5.
To date cyclosporine is the only immunosuppressive drug approved for the treatment of uveitis in Germany. However, side effects often limit its use in daily practice. Voclosporin (Luveniq) represents a next generation calcineurin inhibitor which had shown efficacy in an animal model of experimental autoimmune uveitis as well as in clinical trials for the prevention of renal allograft rejection and for plaque psoriasis. The LUMINATE program included three prospective, randomized, double-masked, placebo-controlled multicenter trials which demonstrated the efficacy and tolerability of voclosporin 0.4 mg/kg b.i.d. in noninfectious intermediate and posterior uveitis and panuveitis. In Europe, the Marketing Approval Application (MAA) of voclosporin for the treatment of uveitis was submitted to the European Medicines Agency (EMA) in February 2010 and could be approved in March 2011.
迄今为止,环孢素是德国唯一被批准用于治疗葡萄膜炎的免疫抑制药物。然而,副作用常常限制了它在日常临床中的使用。voclosporin(商品名:Luveniq)是新一代钙调神经磷酸酶抑制剂,已在实验性自身免疫性葡萄膜炎动物模型以及预防肾移植排斥反应和斑块状银屑病的临床试验中显示出疗效。LUMINATE项目包括三项前瞻性、随机、双盲、安慰剂对照的多中心试验,这些试验证明了voclosporin 0.4mg/kg每日两次在非感染性中间葡萄膜炎、后葡萄膜炎和全葡萄膜炎中的疗效和耐受性。在欧洲,voclosporin治疗葡萄膜炎的上市许可申请(MAA)于2010年2月提交给了欧洲药品管理局(EMA),并于2011年3月获得批准。