经眼玻璃体给药药物的研究进展及非临床研究的考虑要点  

Research progress and considerations on non-clinical studies of the drugs administered through the ocular vitreous body

作　　者：付淑军 于冰 廖琴 孙涛 FU Shu-jun;YU Bing;LIAO Qin;SUN Tao(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Joinn Laboratories(Suzhou),Taicang 215421,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]昭衍(苏州)新药研究中心股份有限公司,江苏太仓215421

出　　处：《药学学报》2023年第4期815-825,共11页Acta Pharmaceutica Sinica

摘　　要：近年来,随着眼科治疗药物的发展,玻璃体作为眼科疾病尤其是眼底病药物治疗的通道,为以湿性年龄相关性黄斑变性(wet age-related macular degeneration,wAMD)为代表的各种脉络膜新生血管性疾病、眼底病并发的黄斑水肿、葡萄膜炎等疾病的治疗开辟了新的治疗途径。经眼玻璃体给药的药物主要包括眼用抗血管内皮生长因子(vascular endothelial growth factor,VEGF)类注射剂、微纤溶酶及激素等。对于该类眼科产品,目前国内外尚无明确的非临床研究技术指导原则和规范可循。本文结合审评实践和已上市产品的研发案例,梳理了经眼玻璃体给药药物的研究进展及非临床研究评价考虑要点,以期为该类药物的研究评价提供参考。In recent years,with the development of ophthalmic therapeutic drugs,the vitreous body,as a channel for the treatment of ophthalmic diseases,especially fundus diseases,has opened up a new therapeutic approach for various choroidal neovascular diseases,macular edema,uveitis and other diseases associated with fundus diseases,which is represented by wet age-related macular degeneration(wAMD).The drugs administered through the vitreous body mainly include ocular anti-vascular endothelial growth factor(VEGF)injections,microplasmin and hormones.For this kind of ophthalmic products,there are no clear technical guidelines and norms for non-clinical research at home and abroad.This article combines review practices and cases of marketed products to sort out the research progress and considerations on non-clinical studies of ophthalmic drugs dosing through the ocular vitreous body,in order to provide references for the research and evaluation of such drugs.

关 键 词：眼科治疗药物 玻璃体 经眼玻璃体给药药物 非临床研究 

分 类 号：R969[医药卫生—药理学]