Research progress and considerations on non-clinical studies of the drugs administered through the ocular vitreous body
10.16438/j.0513-4870.2022-1256
- VernacularTitle: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
- Author:
Shu-jun FU
1
;
Bing YU
1
;
Qin LIAO
2
;
Tao SUN
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
2. Joinn Laboratories (Suzhou), Taicang 215421, China
- Publication Type:Research Article
- Keywords:
ophthalmic therapeutic drug;
vitreum;
rugs administered through the vitreous body;
non-clinical study
- From:
Acta Pharmaceutica Sinica
2023;58(4):815-825
- CountryChina
- Language:Chinese
-
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.
