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【Portfolio】维眸生物自主研发的青光眼双靶点创新药VVN539完成美国II期临床首例患者入组

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​​文章来源:维眸生物

2022年7月8日,维眸生物科技(上海)有限公司(“维眸生物”)聚焦差异化和全球新开发的眼科创新药公司,宣布其自主研发的双靶点药物VVN539,针对开角型青光眼患者的美国II期临床研究,在美国纽约州的Rochester Ophthalmological Group完成首例患者入组。这也标志着国内首个青光眼自主创新药的开发,进入了快速推进阶段,未来将为广大青光眼患者创造更多的临床价值。

本临床研究是一项在开角型青光眼或高眼压症患者中,评估VVN539滴眼液安全性和有效性的随机、双盲、溶媒对照、剂效探索的II期临床试验。计划在美国7家研究中心入组约60位受试者,接受为期3周的治疗,并分别在第7、14、21天评估与安慰剂相比较基线的眼压变化值。

 

VVN539是维眸生物自主研发并拥有全球知识产权的一款滴眼用药。目前,开角型青光眼的一线治疗仍以前列腺素类似物为主,但现有药物机制单一,降压效果有限或部分病人不能受益,药物安全性仍有待提高。VVN539作为新一代、具有双靶点机制的药物,直接作用于眼部小梁网,增加房水外流,以达到理想的降低眼压的效果,预期降压能力将不亚于前列素类药物,并具有和其它机制药物形成复方的巨大潜力。

李晓燕 博士 维眸生物CMO

“这项临床试验的启动对于维眸生物来说是一个重要的里程碑,我们在不断地为未满足的临床需求积极开发创新疗法。VVN539作为国内首个自主研发用于治疗青光眼的创新药意义重大,我们将加速在临床阶段探索VVN539的安全性、最优剂量和用药频次,造福广大青光眼患者群体。”

关于VVN539

VVN539是新一代、具有双靶点机制的降眼压药物,直接作用于眼部小梁网,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。VVN539也是维眸生物继VVN001后又一进入临床阶段项目,该项目有望成为具有全球竞争力的眼科创新药。

 

关于青光眼

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。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。

 

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研发团队和技术平台,依托自主研发已经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VVN001、VVN539正处于临床阶段的项目外,用于治疗葡萄膜炎的VVN461的中国I期临床试验也即将展开。

 

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