safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2025-406safetyrisk-406Research ArticleДОКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯPRECLINICAL STUDIESДоклинические исследования офтальмотоксичности лекарственных средств: обзор регуляторных подходов и методов исследованияPreclinical Ophthalmotoxicity Studies of Medicinal Products: a Review of Regulatory Approaches and Research Methodshttps://orcid.org/0000-0002-2119-4233НауменкоЛ. В.NaumenkoL. V.

Науменко Людмила Владимировна, д-р мед. наук

Площадь Павших борцов, д. 1, Волгоград, 400131

Liudmila V. Naumenko, Dr. Sci. (Med.)

1 Pavshikh Bortsov Sq., Volgograd 400131

milanaumenko@mail.ruhttps://orcid.org/0000-0002-8585-4755ГовороваЮ. А.GovorovaYu. A.

Говорова Юлия Александровна, канд. мед. наук

Площадь Павших борцов, д. 1, Волгоград, 400131

Yulia A. Govorova, Cand. Sci. (Med.)

1 Pavshikh Bortsov Sq., Volgograd 400131

https://orcid.org/0000-0001-8477-254XТаранА. С.ТаrаnA. S.

Таран Алена Сергеевна, канд. мед. наук

Площадь Павших борцов, д. 1, Волгоград, 400131

Alena S. Таrаn, Cand. Sci. (Med.)

1 Pavshikh Bortsov Sq., Volgograd 400131

Федеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской ФедерацииРоссияVolgograd State Medical UniversityRussian Federation202518122025134411425Copyright © Науменко Л.В., Говорова Ю.А., Таран А.С., 20252025Науменко Л.В., Говорова Ю.А., Таран А.С.Naumenko L.V., Govorova Y.A., Таrаn A.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/406ВВЕДЕНИЕ

ВВЕДЕНИЕ. Оценка офтальмотоксичности потенциальных лекарственных средств является высокоинформативным элементом доклинических исследований, раскрывающим механизмы действия и фармакологические эффекты химического соединения на орган зрения при местном и системном применении. Однако единый алгоритм оценки офтальмотоксичности в настоящее время отсутствует, что свидетельствует о целесообразности изучения и обобщения российского и зарубежного опыта.

ЦЕЛЬ

ЦЕЛЬ. Разработка алгоритма оценки офтальмотоксичности лекарственных препаратов в доклинических исследованиях in vivo на основе российских и международных рекомендаций.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Проведен анализ подходов к изучению офтальмотоксичности химических соединений в российских и международных нормативных документах (Руководство по проведению доклинических исследований лекарственных средств, ГОСТ 34658-2020, Руководство Организации экономического сотрудничества и развития (OECD) № 450 и № 263). Показано, что рекомендуемые методы применимы в доклинических исследованиях лекарственных препаратов и позволяют изучать влияние химических соединений на структуру (офтальмоскопия, биомикроскопия, оптическая когерентная томография) и функциональные параметры (электроретинография) глаза. Представлена основная информация о сравнительной анатомии и физиологии органа зрения мышей, крыс и кроликов, имеющая значение при исследовании раздражающего глаза и ретинотоксического эффектов и трансляции результатов в клинические исследования. Приведено содержательное описание методов исследования офтальмотоксичности и особенностей их практического применения у основных видов лабораторных животных с учетом особенностей их анатомии и физиологии. В результате обобщения изученных данных предложен комплексный дифференциальный подход к исследованию офтальмотоксичности разрабатываемых лекарственных препаратов.

ВЫВОДЫ

ВЫВОДЫ. Предложенный алгоритм оценки токсического действия на глаза лекарственных препаратов как для офтальмологического, так и системного применения позволяет оптимизировать дизайн и сроки проведения доклинических исследований с использованием лабораторных животных и повысить безопасность применения препаратов у человека.

INTRODUCTION

INTRODUCTION. Ophthalmotoxicity assessment of potential drugs is a highly meaningful element of preclinical trials that reflects modes of action and pharmacological effects of a chemical compound on the eyes in topical and systemic use. However, there is no relevant common algorithm for ophthalmotoxicity assessment, suggesting expediency of summarising Russian and foreign experience.

AIM

AIM. This study aimed to develop an algorithm assessing ophthalmotoxicity of medicinal products in preclinical in vivo studies based on Russian and international guidelines.

DISCUSSION

DISCUSSION. Study approaches of chemical compound ophthalmotoxicity were analysed in Russian and international regulatory documents (Guidelines for conducting preclinical studies of medicines, GOST 34658-2020, Guidelines of Organisation for Economic Co-operation and Development (OECD) No. 450 and No. 263). The recommended methods prove to be applicable in preclinical studies and make it possible to study the effect of chemical compounds on the structure (ophthalmoscopy, biomicroscopy, optical coherence tomography) and functions (electroretinography) of the eyes. The study included basic information on the comparative eye anatomy and physiology in mice, rats, and rabbits, crucial for studying irritant and retinotoxic effects and translating the results into clinical trials. Ophthalmotoxicity research methods and their practical application in typical laboratory animals were described in detail considering their anatomy and physiology. Based on generalised study data, a comprehensive differential approach is proposed for ophthalmotoxicity study of the developed medicinal products.

CONCLUSIONS

CONCLUSIONS. The proposed algorithm assessing ocular toxicity of ophthalmic and systemic drugs makes it possible to optimise the design and schedule of preclinical studies in animals and improve the safety of drug use in humans.

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The authors declare that there are no conflicts of interest present.