2014年12月24日訊 /生物谷BIOON/ --眼科護理的全球領導者——諾華旗下眼科單元愛爾康（Alcon）近日宣布，已上市青光眼藥物Travatan（曲伏前列素滴眼液，40微克/毫升）收穫歐盟兒科適應症。歐盟委員會（EC）已批准Travatan用於青光眼或高眼壓症兒科（2月-18歲）患者，降低患者升高的眼內壓（IOP）。此前，Travantan的適應症為用於高眼壓症或開角型青光眼成人患者降低IOP。
Travatan兒科適應症的獲批，意味著歐洲的眼科醫生擁有了一種新的處方藥，以幫助控制兒童和青少年控制升高的眼內壓（IOP）。
青光眼（glaucoma）是繼白內障之後導致不可逆失明的第二大病因，全球有超過6000萬患者。用藥物降低眼內壓是目前已知可改變青光眼風險因素的唯一方法，但患者必須終身定期用藥。目前，青光眼的確切病因尚不明確。
Travantan兒科適應症的獲批，是基於一項為期12周的多中心雙盲隨機平行組III期研究（n=152），主要終點是第12周時升高的眼內壓（IOP）從基線的變化。研究結果表明，Travantan從治療的第2周開始表現出降低IOP療效，這種療效在整個12周期間均得以保持。平均IOP降低幅度在Travantan治療組和噻嗎洛爾（timolol）治療組相似，證明了成人劑量的Travantan在兒科（2個月-18歲）患者中具有很好的療效和安全性。針對2月以下的兒科患者，Travantan的相關數據尚未獲得。在臨床研究中，兒科患者中最常見的藥物不良反應為眼充血和睫毛生長。
在歐盟，Travantan是首個也是唯一一種不含苯扎氯銨（BAK）的前列腺素類似物。既往開展的成人研究表明，Travantan具有較強的降眼壓效果，在一天中能將眼壓降低30%。
作為眼科護理的全球領導者，愛爾康致力於開發廣泛的解決方案，用於眼科疾病的管理和護理。青光眼方面，愛爾康擁有多種產品幫助降低眼壓，包括Simbrinza，Travantan，Duotrav，Azarga，Zaopt，Izba。（生物谷Bioon.com）
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.