Patrick Hughes, Hongwen M Rivers, Vladimir Bantseev, Chun-Wan Yen, Hanns-Christian Mahler, Swati Gupta
{"title":"Intraocular delivery considerations of ocular biologic products and key preclinical determinations.","authors":"Patrick Hughes, Hongwen M Rivers, Vladimir Bantseev, Chun-Wan Yen, Hanns-Christian Mahler, Swati Gupta","doi":"10.1080/17425247.2023.2166927","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Ophthalmic diseases of the retina are a significant cause of vision loss globally. Despite much progress, there remains an unmet need for durable, long-acting treatment options. While biologic therapies show great promise, they present many challenges, including complexities in biochemical properties, mechanism of action, manufacturing considerations, preclinical evaluation, and delivery mechanism; these are confounded by the unique anatomy and physiology of the eye itself.</p><p><strong>Areas covered: </strong>This review describes the current development status of intravitreally administered drugs for the treatment of ophthalmic disease, outlines the range of approaches that can be considered for sustained drug delivery to the eye, and discusses key preclinical considerations for the evaluation of ocular biologics.</p><p><strong>Expert opinion: </strong>The required frequency of dosing in the eye results in a great burden on both patients and the health care system, with direct intraocular administration remaining the most reliable and predictable route. Sustained and controlled ophthalmic drug delivery systems will go a long way in reducing this burden. Sustained delivery can directly dose target tissues, improving bioavailability and reducing off-target systemic effects. Maintaining stability and activity of compounds can prevent aggregation and enable extended duration of release, while sustaining dosage and preventing residual polymer after drug depletion.</p>","PeriodicalId":12229,"journal":{"name":"Expert Opinion on Drug Delivery","volume":"20 2","pages":"223-240"},"PeriodicalIF":5.0000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Drug Delivery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17425247.2023.2166927","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 1
Abstract
Introduction: Ophthalmic diseases of the retina are a significant cause of vision loss globally. Despite much progress, there remains an unmet need for durable, long-acting treatment options. While biologic therapies show great promise, they present many challenges, including complexities in biochemical properties, mechanism of action, manufacturing considerations, preclinical evaluation, and delivery mechanism; these are confounded by the unique anatomy and physiology of the eye itself.
Areas covered: This review describes the current development status of intravitreally administered drugs for the treatment of ophthalmic disease, outlines the range of approaches that can be considered for sustained drug delivery to the eye, and discusses key preclinical considerations for the evaluation of ocular biologics.
Expert opinion: The required frequency of dosing in the eye results in a great burden on both patients and the health care system, with direct intraocular administration remaining the most reliable and predictable route. Sustained and controlled ophthalmic drug delivery systems will go a long way in reducing this burden. Sustained delivery can directly dose target tissues, improving bioavailability and reducing off-target systemic effects. Maintaining stability and activity of compounds can prevent aggregation and enable extended duration of release, while sustaining dosage and preventing residual polymer after drug depletion.
期刊介绍:
Expert Opinion on Drug Delivery (ISSN 1742-5247 [print], 1744-7593 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles covering all aspects of drug delivery research, from initial concept to potential therapeutic application and final relevance in clinical use. Each article is structured to incorporate the author’s own expert opinion on the scope for future development.