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【Portfolio】维眸生物用于治疗青光眼的双靶点机制VVN539正式递交美国II期临床试验申请

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​​文章来源:维眸生物 http://www.vivavisionbio.com/

中国领先的眼科创新药公司维眸生物科技(上海)有限公司(“维眸生物”)宣布,公司已于2022年05月05日向FDA递交了用于治疗开角型青光眼新药VVN539的II期临床试验申请,并将于2022年6月份启动该项临床研究。

青光眼(Glaucoma)是眼压升高或超过视神经耐受而引起的视神经损害从而导致视力丧失,是全球三大致盲眼病之一。在中国,青光眼致盲率高达到22.7%,为导致不可逆性盲的首要原因。青光眼总人群发病率约为1%,40岁以上、有青光眼家族史、眼压高于正常值、高度近视或远视、高血压、糖尿病、较长时间全身或眼部使用糖皮质激素、眼外伤史——这些都是青光眼的高危因素。降低眼压以达到保护视神经是现今被证实有效的青光眼的治疗的唯一手段。需要注意的是,一旦确诊为青光眼,规范用药控制眼压,是对视功能最有效的保护。

 

 

临床上根据病因、房角、眼压描记等因素,青光眼分为原发性、继发性和先天性,其中原发性青光眼占绝大多数。原发性青光眼又根据房水循环受阻的原因不同,分为开角型(POAG)和闭角型(PACG)两大类。原发性开角型青光眼表现为进展性视神经节及其轴突细胞受损,导致视神经萎缩、视野变小直至失明。大部分原发性开角型青光眼病人检测到眼压可升高,但也有少部分青光眼病人眼压正常但视神经持续损伤(正常眼压型青光眼)。开角型青光眼发病机制尚未完全阐明,但可能与小梁网的结构和功能受损有关。目前原发性开角型青光眼的治疗主要以滴眼药物降低眼压到正常偏低范围为主。

 

开角型青光眼目前一线治疗以前列腺素类似物为主,现有药物中机制单一,降压效果有限,药物安全性仍有待提高,急需新机制药物为治疗提供更多选择。国内已上市青光眼治疗药物暂无主要作用于小梁网通路的机制。VVN539是新一代、具有双靶点机制的降眼压药物,其通过作用于眼部小梁网,增加房水外流,从而达到降低眼压的效果。在临床前动物模型中,VVN539表现出优异的降眼压效果。

中国开角型青光眼约占青光眼总数的一半。中国近视人口比例正在快速上升,尤其是高度近视者患者群体的扩大也会直接影响着中国开角型青光眼发病率升高。近年来国家高度重视眼健康工作,“十四五”全国眼健康规划进一步强调对致盲性疾病的关注,倡导青光眼的早发现、早诊断、早治疗,并制定诊疗规范,降低致盲率。随着经济社会发展及人口老龄化进程加剧,人民群众对眼健康有了更高需求,中国青光眼用药市场也会随之快速扩增。VVN539是维眸公司继VVN001后又一进入临床阶段项目,有望成为具有全球竞争力的眼科创新药。

 

关于维眸生物

维眸生物是一家专注于眼科治疗领域的临床阶段生物科技公司,拥有国际一流的眼科创新药物研发团队和技术平台,已依托自主研发建立起具有全球竞争力的产品管线,包括First-in-Class和Best-in-Class产品。除正处于临床阶段的VVN001和VVN539两款滴眼液新药研发项目,拟用于治疗非感染性葡萄膜炎的VVN461滴眼液也即将在中国展开临床研究。

 

更多信息,请访问网站:www.vivavisionbio.com

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