Welcome to visit Zhongnan Medical Journal Press Series journal website!

Home Articles Vol 28,2024 No.2 Detail

Current status and quality evaluation of domestic and foreign ophthalmic drug and device combination products

Published on Nov. 08, 2024Total Views: 195 times Total Downloads: 15 times Download Mobile

Author: WEI Zhihan 1, 2 HUANG Yuanli 1 ZHAO Danmei 1 DU Xiaodan 1 KE Linnan 1 XU Yun 2

Affiliation: 1. National Institutes for Food and Drug Control , Beijing 102629, China 2. College of Engineering, China Pharmaceutical University , Nanjing 210009, China

Keywords: Ophthalmology Drug-device combination products Corneal contact lenses Punctual plugs Intraocular lens Quality evaluation

DOI: 10.12173/j.issn.2097-4922.202407043

Reference: WEI Zhihan, HUANG Yuanli, ZHAO Danmei, DU Xiaodan, KE Linnan, XU Yun.Current status and quality evaluation of domestic and foreign ophthalmic drug and device combination products[J].Yaoxue QianYan Zazhi,2024, 28(2):350-356.DOI: 10.12173/j.issn.2097-4922.202407043.[Article in Chinese]

  • Abstract
  • Full-text
  • References
Abstract

Ophthalmic drug-device combination products are a new method of ophthalmic disease treatment, which is characterized by high bioavailability, strong targeting and good compliance. However, it is difficult for products to be developed and regulated due to the complexity of the human eye structure, drug-device interactions, and other factors. To provide a basis for guaranteeing the safety and efficacy of products development and management, the related regulations, current research, and evaluation of the quality of products are summarized in this paper.

Full-text
Please download the PDF version to read the full text: download
References

1.World Health Organization. World Report on Vision[EB/ OL]. (2019-10-08) [2024-03-02]. https://www.who.int/publications/i/item/9789241516570.

2.中华医学会眼科学分会眼底病学组, 中国医师协会眼科医师分会眼底病学组. 中国年龄相关性黄斑变性临床诊疗指南(2023年)[J]. 中华眼科杂志, 2023, 59(5): 347-366. DOI: 10.3760/cma.j.cn112142-20221222-00649.

3.施方震, 朱文豪, 陶涛,等. 眼科药械组合产品的应用进展[J]. 中国医药工业杂志, 2023, 54(5): 700-710. [Shi  FZ, Zhu WH, Tao T, et al. Progress in the application of ophthalmic drug-device combination products[J]. Chinese Journal of Pharmaceuticals, 2023, 54(5): 700-710.] DOI: 10.16522/j.cnki.cjph.2023.05.008.

4.Rupnthal ID. Drug-device combination approaches for delivery to the eye[J]. Curr Opin Pharmacol, 2017, 36: 44-51. DOI: 10.1016/j.coph.2017.08.003.

5.Kumoluyi R, Khanolkar A. Risk Management in drug-device combination product development[J]. Ther Innov Regul Sci, 2022, 56(5): 685-688. DOI: 10.1007/s43441-022-00425-w.

6.国家药品监督管理局. 国家药监局关于药械组合产品注册有关事宜的通告(2021年第52号) [EB/OL]. (2021-07-27) [2024-03-05]. https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20210727154135199.html.

7.田佳鑫, 王永清, 许伟. 研究改进机械组含产品联合审评工作的思考[J]. 中国医疗器械杂志, 2022, 46(4): 365-367. [Tian JX, Wang YQ, Xu W. Thoughts on improving joint review of combination products[J]. Chinese Journal of Medical lnstrumentation, 2022, 46(4): 365-367.]. DOI: 10.3969/j.issn.1671-7104.2022.04.003.

8.刘凤林, 柴谦, 郭金双, 等. 药械组合产品质量管理体系建立及监管的探讨[J]. 中国医疗器械信息, 2022, 28(13): 10-12. [Liu FL, Chai Q, Guo JH, et al. Discussion on the establishment and supervision of quality management system of pharmaceutical and mechanical combination products[J]. China Medical Device Information, 2022, 28(13): 10-12.] DOI: 10.3969/j.issn.1006-6586.2022.13.002.

9.国家药品监督管理局. 国家药监局关于发布以医疗器械作用为主的药械组合产品等2项注册审查指导原则的通告(2022年第3号) [EB/OL]. (2022-01-17) [2024-03-05] https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20220117145645132.html.

10.Xu J, Li X, Sun F. In vitro and in vivo evaluation of ketotifen fumarate-loaded silicone hydrogel contact lenses for ocular drug delivery[J]. Drug Deliv, 2011, 18(2): 150-158. DOI: 10.3109/10717544.2010.522612.

11.Dipasquale SA, Wuchte LD, Mosley RJ, et al. One week sustained in vivo therapeutic release and safety of novel extended-wear silicone hydrogel contact lenses[J]. Adv Healthc Mater, 2022, 11(7): e2101263. DOI: 10.1002/adhm.202101263.

12.Lee D, Cho S, Park HS, et al. Ocular drug delivery through pHEMA-hydrogel contact lenses co-loaded with lipophilic vitamins[J]. Sci Rep, 2016, 6: 34194. DOI: 10.1038/srep34194.

13.NichollsI IA, Chavan S, Golker K, et al. Theoretical and computational strategies for the study of the molecular imprinting process and polymer performance[J]. Adv Biochem Eng Biotechnol, 2015, 150: 25-50. DOI: 10.1007/10_2015_318.

14.Qin C, Liu S, Wen S, et al. Enhanced PCO prevention of drug eluting IOLs via endocytosis and autophagy effects of a PAMAM dendrimer[J]. J Mater Chem B, 2021, 9(3): 793-800. DOI: 10.1039/d0tb02530e.

15.Zhang X, Lai K, Li S, et al. Drug-eluting intraocular lens with sustained bromfenac release for conquering posterior capsular opacification[J]. Bioact Mater, 2022, 9: 343-357.DOI: 10.1016/j.bioactmat.2021.07.015.

16.Zhang X, Wang J, Xu J, et al. Prophylaxis of posterior capsule opacification through autophagy activation with indomethacin-eluting intraocular lens[J]. Bioact Mater, 2023, 23: 539-550. DOI: 10.1016/j.bioactmat.

17.Lu D, Han Y, Liu D, et al. Centrifugally concentric ring-patterned drug-loaded polymeric coating as an intraocular lens surface modification for efficient prevention of posterior capsular opacification[J]. Acta Biomater, 2022, 138: 327-341. DOI: 10.1016/j.actbio.2021.11.018.

18.Qin C, Liu S, Wen S, et al. Enhanced PCO prevention of drug eluting IOLs via endocytosis and autophagy effects of a PAMAM dendrimer[J]. Mater Chem B, 2021, 9(3): 793-800. DOI: 10.1039/d0tb02530e.

19.Kaido M, Ishida R, Dogru M, et al. Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease[J]. Am J Ophthalmol, 2013, 155(4): 648-653, 653.e1. DOI: 10.1016/j.ajo.2012.10.024.

20.Marcet MM, Shtein RM, Bradley EA, et al. Safety and efficacy of lacrimal drainage system plugs for dry eye syndrome: a report by the american academy of ophthalmology[J]. Ophthalmology, 2015, 122(8): 1681-1687. DOI: 10.1016/j.ophtha.2015.04.034.

21.Lee A, Blair HA. Dexamethasone intracanalicular insert: a review in treating post-surgical ocular pain and inflammation[J]. Drugs, 2020, 80(11): 1101-1108. DOI: 10.1007/s40265-020-01366-0.

22.Casson RJ. Medical therapy for glaucoma: a review[J]. Clin Exp Ophthalmol, 2022, 50(2): 198-212. DOI: 10.1111/ceo.13989.

23.Sirinek PE, Lin MM. Intracameral sustained release bimatoprost implants (Durysta)[J]. Semin Ophthalmol, 2022, 37(3): 385-390. DOI: 10.1080/08820538.2021.1985145.

24.Mohan N, Chakrabarti A, Nazm N, et al. Newer advances in medical management of glaucoma [J]. Indian J Ophthalmol, 2022, 70(6): 1920-1930. DOI: 10.4103/ijo.ijo_2239_21.

25.Shirley M. Bimatoprost implant: first approval[J]. Drugs Aging, 2020, 37(6): 457-462. DOI: 10.1007/s40266-020-00769-8.

26.Miller PE, Eaton JS. Medical anti-glaucoma therapy: beyond the drop[J]. Vet Ophthalmol, 2021, 24 Suppl 1: 2-15. DOI: 10.1111/vop.12843.

27.Rubiao F, Araujo ACF, Sancio JB, et al. Topical bimatoprost insert for primary open-angle glaucoma and ocular hypertension treatment-a phase II controlled study[J]. Curr Drug Deliv, 2021, 18(7): 1022-1026. DOI: 10.2174/1567201818666210101112256.

28.Belamkar A, Harris A, Zukerman R, et al. Sustained release glaucoma therapies: novel modalities for overcoming key treatment barriers associated with topical medications[J]. Ann Med, 2022, 54(1): 343-358. DOI: 10.1080/07853890.2021.1955146.

29.张婷, 王丽强, 顾建军,等. 领扣型人工角膜治疗高危移植角膜盲的多中心临床研究[J] .中华眼科杂志, 2023, 59(4): 262-271. [Zhang T, Wang LQ, Gu JJ, et al. A multicenter clinical study of collar-and-button artificial cornea for the treatment of high-risk transplanted corneal blindness[J] . Chinese Journal of Ophthalmology, 2023, 59(4): 262-271.] DOI: 10.3760/cma.j.cn112142-20221103-00565.

30.Zhang Y, Hu Z, Qu J, et al. Tissue-engineered corneal endothelial sheets using ultrathin acellular porcine corneal stroma substrates for endothelial keratoplasty[J]. ACS Biomater Sci Eng, 2022, 8(3): 1301-1311. DOI: 10.1021/acsbiomaterials.2c00039.

31.An JH, Park SY, Kim GH, et al. Tissue engineered ultra-thin descemet stripping corneal endothelial layers using porcine cornea and stem cells[J]. Exp Eye Res, 2020, 199: 108192. DOI: 10.1016/j.actbio.2022.03.039.

32.Qi Q, Wei Y, Zhang X, et al. Challenges and strategies for ocular posterior diseases therapy via non-invasive advanced drug delivery[J]. J Control Release, 2023, 361: 191-211. DOI: 10.1016/j.jconrel.2023.07.055.

33.De Francesco T, Ahmed IIK. Surgical augmentation of the suprachoroidal space: a novel material and implant[J]. Clin Ophthalmol, 2023, 17: 2483-2492. DOI: 10.2147/opth.s409958.

34.Jung JH, Chae JJ, Prausnitz MR. Targeting drug delivery within the suprachoroidal space[J]. Drug Discov Today, 2019, 24(8): 1654-1659. DOI: 10.1016/j.drudis.2019.03.027.

35.Fung S, Syed YY. Suprachoroidal space triamcinolone acetonide: a review in uveitic macular edema [J]. Drugs, 2022, 82(13): 1403-1410. DOI: 10.1007/s40265-022-01763-7.

36.国家质量监督检验检疫总局. 眼科光学 接触镜. GB/T 11417-2012[S]. 2012.

37.国家市场监督管理总局. 医疗器械生物学评价 第1部分: 风险管理过程中的评价与试验. GB/T 16886.1-2022[S]. 2022.

38.Gangadhar RS, Balamuralidhara, Rajeshwari SR. Biocompatibility of medical devices-a review[J]. J Evolution Med Dental Sci, 2021, 10(36): 3152-3158. DOI: 10.14260/jemds/2021/641.

39.Pereira-da-Mota AF, Phan CM, Concheiro A, et al. Testing drug release from medicated contact lenses: the missing link to predict in vivo performance[J]. J Control Release, 2022, 343: 672-702. DOI: 10.1016/j.jconrel.2022.02.014.

40.Gerde P, Malmlö FM, Selg E. In vitro to ex vivo/in vivo correlation (IVIVC) of dissolution kinetics from inhaled particulate solutes using air/blood barrier models: relation between in vitro design, lung physiology and kinetic output of models[J]. J Aerosol Sci, 2021, 151. DOI: 10.1016/j.jaerosci.2020.105698.

41.Pereira-da-Mota AF, Vivero-Lopez M, Garg P, et al. In vitro-in vivo correlation of drug release profiles from medicated contact lenses using an in vitro eye blink model[J]. Drug Deliv Transl Res, 2022, 13(4): 1116-1127. DOI: 10.1007/s13346-022-01276-6.

42.田佳鑫, 王永清, 许伟,等. 药械组合产品申报资料常见问题分析[J].中国医疗器械杂志, 2020, 44(1): 68-70. [Tian JX, Wang YQ, Xu W, et al. Analysis of common problems in product declaration information of pharmaceutical and device combinations[J]. Chinese Journal of Medical Devices, 2020, 44(1): 68-70.] DOI: 10.3969/j.issn.1671-7104.2020.01.015.

43.中国食品药品检定研究院. 2023——2024年度药械组合产品属性界定结果汇总[EB/OL]. (2024-07-04) [2024-08-15]. https://www.nifdc.org.cn/directory/web/nifdc/bshff/ylqxbzhgl/qxxxgk/yxzh/202407041535131143585.html.

Popular papers
Last 6 months