2014年12月24日讯 /生物谷BIOON/ --眼科护理的全球领导者——诺华旗下眼科单元爱尔康（Alcon）近日宣布，已上市青光眼药物Travatan（曲伏前列素滴眼液，40微克/毫升）收获欧盟儿科适应症。欧盟委员会（EC）已批准Travatan用于青光眼或高眼压症儿科（2月-18岁）患者，降低患者升高的眼内压（IOP）。此前，Travantan的适应症为用于高眼压症或开角型青光眼成人患者降低IOP。
Travatan儿科适应症的获批，意味着欧洲的眼科医生拥有了一种新的处方药，以帮助控制儿童和青少年控制升高的眼内压（IOP）。
青光眼（glaucoma）是继白内障之后导致不可逆失明的第二大病因，全球有超过6000万患者。用药物降低眼内压是目前已知可改变青光眼风险因素的唯一方法，但患者必须终身定期用药。目前，青光眼的确切病因尚不明确。
Travantan儿科适应症的获批，是基于一项为期12周的多中心双盲随机平行组III期研究（n=152），主要终点是第12周时升高的眼内压（IOP）从基线的变化。研究结果表明，Travantan从治疗的第2周开始表现出降低IOP疗效，这种疗效在整个12周期间均得以保持。平均IOP降低幅度在Travantan治疗组和噻吗洛尔（timolol）治疗组相似，证明了成人剂量的Travantan在儿科（2个月-18岁）患者中具有很好的疗效和安全性。针对2月以下的儿科患者，Travantan的相关数据尚未获得。在临床研究中，儿科患者中最常见的药物不良反应为眼充血和睫毛生长。
在欧盟，Travantan是首个也是唯一一种不含苯扎氯铵（BAK）的前列腺素类似物。既往开展的成人研究表明，Travantan具有较强的降眼压效果，在一天中能将眼压降低30%。
作为眼科护理的全球领导者，爱尔康致力于开发广泛的解决方案，用于眼科疾病的管理和护理。青光眼方面，爱尔康拥有多种产品帮助降低眼压，包括Simbrinza，Travantan，Duotrav，Azarga，Zaopt，Izba。
英文原文：Alcon treatment Travatan® receives EU approval for pediatric glaucoma patients
New indication to decrease elevated intraocular pressure in patients, aged two months to less than 18 years, with ocular hypertension or pediatric glaucoma[1]
Pediatric indication complements Alcon's broad treatment portfolio in glaucoma, providing a new important prostaglandin-based therapy for young patients
Glaucoma is a life-long, irreversible eye disease that can progressively lead to blindness if left untreated or not adequately managed[1]
Basel, Switzerland, December 23, 2014 - Alcon, the global leader in eye care and second-largest division of Novartis, announced that its treatment for patients with glaucoma, Travatan® (40µg/mL travoprost) Eye Drops Solution, has been granted an additional indication by the European Commission to decrease elevated intraocular pressure (IOP) in pediatric patients, aged two months to less than 18 years, with ocular hypertension or pediatric glaucoma.[2] Travatan® is currently indicated to decrease elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma.
Glaucoma is a progressive eye disease that damages the optic nerve,[3] resulting in gradual, irreversible loss of vision, and eventually blindness if left untreated or not adequately managed.[4] Elevated eye pressure, or IOP, is considered the main risk factor for glaucoma.[5]
"Pediatric glaucoma affects only a small number of children worldwide, so there is little data available about how to manage this sight-threatening disease in pediatric patients," said Professor Stefano Gandolfi, MD, Head of Eye Clinic, University of Parma, Italy. "The Travatan® approval for this additional indication means that ophthalmologists now have a new medicine to prescribe to help children and adolescents control their IOP level every day."
Pediatric glaucoma is responsible for 5%[2] of childhood blindness worldwide. Patients suffering from glaucoma have no cure and, if vision is lost, it cannot be restored. Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops, or in the most severe cases, with surgery.[6],[7]
"We are pleased to receive the new EU pediatric indication of Travatan®, which further strengthens Alcon's globally-leading glaucoma portfolio. The addition of this indication demonstrates Alcon's long-term commitment and dedication to alleviating the patient burden of this sight-threatening disease," said Jeff George, Global Head of Alcon.
The EU approval is based on a 12-week, Phase III, multicenter, double-masked, randomized, parallel-group study (n=152). The primary efficacy endpoint was the IOP change from baseline at Week 12 of the study. The effect on IOP was seen after the second week of treatment and was consistently maintained throughout the 12-week study period. Mean IOP reductions in the travoprost and timolol groups were similar. Travatran® was shown to be safe and effective for use in children from two months to less than 18 years of age, at the same dose as for adults. No data are available for children below the age of two months. In the clinical study, the most frequently reported adverse drug reactions in pediatric patients were ocular hyperemia and growth of eyelashes.
Travatan®, preserved with POLYQUAD®, is the first and only, multi-dose prostaglandin analogue without benzalkonium chloride (BAK) approved in the EU, In previous clinical studies in adult patients, Travatan® showed strong IOP-lowering efficacy, decreasing IOP by 30%[8] over the course of a day.[9]
Alcon provides a broad spectrum of pharmaceutical and surgical treatment solutions to address the needs of patients at all stages of glaucoma management and care. As a world leader in treatments for glaucoma patients, Alcon is committed to developing solutions for unmet medical needs. Alcon offers a broad range of pharmaceutical treatment options for patients with glaucoma to help lower elevated IOP: Simbrinza®, Travatan®, Duotrav®, Azarga®, Azopt® and Izba®.
About Glaucoma
Glaucoma is a leading cause of blindness, and affects more than 60 million people worldwide. Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision and eventually blindness. There is no cure for glaucoma and vision lost cannot be restored. Medications can lower eye pressure, the only known modifiable risk factor for glaucoma, but must be taken life-long and regularly. The exact cause of glaucoma is unknown.