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 详细处方信息以本药内容附件PDF文件（20119819582536.pdf）的“原文Priscribing Information”为准
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部分中文Cationorm处方资料（仅供参考）

干眼症治疗产品Cationorm在法国上市
Novagali制药公司日前宣布，该公司的新药研究申请（IND）的进行一个关键的第三阶段的临床试验环孢素Nova22007，一个眼的产品，由美国食品和药物管理局（FDA）已授予。

Nova22007是拟用于治疗患有中度至重度干眼症患者的环孢素A眼科产品。 Nova22007是一个专有的阳离子乳化，使环孢素的最佳渗透一个在眼睛表面的组织，从Novasorb（R）的阳离子乳化技术功能的好处。

作为本实业的一部分，FDA已经同意，Novagali可直接进行到关键的第三阶段临床试验在美国与中度至重度干眼症患者。这实业如下一个与FDA于2006年7月举行的第二阶段会议pre-IND/end。 FDA已经审查Novagali产生在欧洲的第二阶段Nova22007与干燥性角结膜炎（干性角膜炎）干燥综合征患者的临床研究数据的质量，安全性和有效性。此外，FDA已经对美国的III期临床试验协议的书面指导。计划，双盲随机车辆控制研究将评估Nova22007疗效，在缓解干眼症的客观和主观的症状。

Novagali制药公司总裁兼首席执行官杰罗姆马丁内斯说，“FDA Nova22007实业间隙为关键的第三阶段研究的一个重要的里程碑，为Novagali，验证我们的眼技术平台Novasorb（R）的”。 “随着我们在欧盟即将举行的第三阶段试验中，两个关键性的研究将使在美国和欧盟注册的产品，和患者提供一种新的和独特的改善干眼症处方产品”。

这种伦理产品是相辅相成的Cationorm（R）致力于干眼症救济Novasorb（R）的功能中受益阳离子乳化。 Cationorm（R）在欧洲获得CE标志，符合作为眼部润滑剂产品，并与美国眼场外专着。

Novagali Pharma Announces The Launch Of Cationorm(R)
Novagali Pharma, an ophthalmic specialty pharmaceutical company announces the commercial launch in France of its first product Cationorm®. This cationic emulsion is an innovative approach to treat dry eye symptoms. It has been developed on the basis of Novagali Pharma patented technology platform Novasorb®.

Dry eye syndrome is the second cause of consultation in ophthalmology. It concerns over 100 million people in the world and 14 % of the adults of more than 40 years. Due to a chronic lack of lubrication and moisture in the eye, its consequences range from irritation to ocular inflammation of the conjunctiva and corneal tissues of the eyes. People with dry eye have sandy-gritty irritation or burning in their eyes. In most severe cases, corneal lesions may lead to vision loss. Specific factors such as ageing populations, pollution, air conditioning, extended use of computers, contribute to an increase in the prevalence of the syndrome and in opportunities for the development of more efficient products.

Cationorm® brings a true innovation to the patients suffering from dry eye symptoms. The cationic emulsion reproduces the tear mechanisms of action to act on the different levels of the tear film. Cationorm® uniquely combines lubricating and hydrating properties, optimal spreading on the surface of the eye, replenishment of the tear film lipid layer and prevention of tear evaporation. The results of clinical study have clearly demonstrated Cationorm® advantages for patients: tolerance, long-lasting relief and optimal comfort.

These advantages are based on Novasorb®, the proprietary cationic emulsion technology platform of Novagali Pharma. Novasorb®, is designed to improve topical administration of ophthalmic medicines. It is based on the electrostatic attraction that occurs between the droplets of a positively-charged emulsion and the negatively charged cells of the ocular surface, including cornea and conjunctiva.

The commercial launch of Cationorm® in Europe and in the United States by the end 2008, where the product complies with the OTC status, is a major event for the development of Novagali Pharma. «Cationorm® commercial launch is very special to us being our first marketed product coming out of our pipeline. It is the result of many years of work for the entire Novagali team and we are very proud of the innovation Cationorm® brings for the treatment of dry eye symptoms », said Jérôme Martinez, CEO of Novagali Pharma.

Cationorm® is a medical device available in France since April 2008. The product is unpreserved and packaged in box of 30 sterile single vials.

A propos de Novagali Pharma
Novagali Pharma is an ophthalmic pharmaceutical company based in the Génopôle biocluster in Evry (France) that develops and commercializes innovative products. Thanks to its proprietary technology platforms Novasorb® and Eyeject®, the company has developed a broad pipeline of 7 innovative products addressing main ocular conditions as well as orphan diseases. Most advanced products include Vekacia®, an orphan product for treatment of vernal keratoconjunctivitis, Cyclokat®, a product for the treatment of moderate-to-severe dry eye syndrome and Cortiject® for the treatment of diabetic retinopathies. Cationorm®, indicated for dry eye symptoms is commercialized in France since April 2008. Founded in 2000, Novagali Pharma has 50 employees.

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 详细处方信息以本药内容附件PDF文件（20119819582536.pdf）的“原文Priscribing Information”为准
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