付淑军, 于冰, 廖琴, 孙涛. 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J. 药学学报, 2023, 58(4): 815-825. DOI: 10.16438/j.0513-4870.2022-1256
引用本文: 付淑军, 于冰, 廖琴, 孙涛. 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J. 药学学报, 2023, 58(4): 815-825. DOI: 10.16438/j.0513-4870.2022-1256
FU Shu-jun, YU Bing, LIAO Qin, SUN Tao. Research progress and considerations on non-clinical studies of the drugs administered through the ocular vitreous bodyJ. Acta Pharmaceutica Sinica, 2023, 58(4): 815-825. DOI: 10.16438/j.0513-4870.2022-1256
Citation: FU Shu-jun, YU Bing, LIAO Qin, SUN Tao. Research progress and considerations on non-clinical studies of the drugs administered through the ocular vitreous bodyJ. Acta Pharmaceutica Sinica, 2023, 58(4): 815-825. DOI: 10.16438/j.0513-4870.2022-1256

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

  • 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。

     

    Abstract: 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.

     

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