IVIEW-1201急性细菌性结膜炎中国II期临床申请获得批准

 IVIEW-1201急性细菌性结膜炎中国II期临床申请获得批准

Application for IVIEW-1201 Phase 2 Clinical Trial in China for The Treatment of Acute Bacterial Conjunctivitis Was Approved

北京时间2022年1月15日，中国药品监督管理局药品审评中心（CDE）正式公布批准艾威药业（珠海）有限公司递交的IVIEW-1201项目急性细菌性结膜炎的II期临床试验申请。

On January 15, 2022, the Center for Drug Evaluation (CDE) of the China Medical Products Administration officially announced the approval of the Phase 2 clinical trial application for treatment of acute bacterial conjunctivitis (IVIEW-1201), which was submitted by IVIEW Pharmaceutical (Zhuhai) Co., Ltd.

全球批准用于治疗细菌感染引起的结膜炎的常用药物包括：阿奇霉素滴眼液、莫西沙星滴眼液、环丙沙星滴眼液、氧氟沙星滴眼液以及氯霉素滴眼液等。由于临床抗生素药物的不合理使用，造成部分致病菌对相关抗生素药物出现耐药性，长期使用疗效会大幅下降，此时使用抗生素药物不仅无法达到治疗效果，还会造成病情延误，增加患者医疗负担。艾威药业自主开发的IVIEW-1201其活性成分已有多年的大量临床用药经验，且至今无耐药性相关报道，差异化作用机制很好地弥补了现阶段由于抗生素药物大量使用而导致的耐药性的缺陷。

Commonly used drugs approved for treatment of bacterial conjunctivitisincludeAzithromycin Eye Drops, Moxifloxacin Eye Drops, Ciprofloxacin Eye Drops, Ofloxacin Eye Drops, and Chloramphenicol Eye Drops. Due to clinical irrational use of antibiotics, some pathogenic bacteria have become resistant to related antibiotic drugs, and the efficacy of long-term use will be greatly reduced. Such use of antibiotics not only fails to achieve the therapeutic effect, but also causes the delays intreatment, which increases the medical burden.

IVIEW-1201此前已经被药品审评中心（CDE）批准开展治疗病毒性结膜炎的II期临床研究，正在全球同步开展国际多中心临床二期试验。结合本次新适应症的获批，IVIEW-1201覆盖感染性结膜炎的全部病因，临床使用时无需甄别感染源，更加安全、有效，有望成为全球第一个治疗广谱感染性结膜炎特效药。

The active ingredient of IVIEW-1201 developed by IVIEW Pharmaceutical has many years of clinical experience in drug use, and so far, no drug resistance is reported. The differentiated mechanism of action makes up for the current defect of drug resistance caused by the extensive use of antibiotics.