Perspective of the Pharmaceuticals and Medical Devices Agency on Drug Development for Childhood Myopia.

IF 5.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2025-10-03 DOI:10.1002/cpt.70086

Mitsuru Arima, Motomasa Atsumi, Kumiko Takeuchi, Takumi Aoki, Emi Inagaki, Yosuke Kobayashi, Takuya Kageyama, Kazuki Izumi, Atsushi Yoshimura, Wataru Asakura

引用次数: 0

Abstract

Pathologic myopia represents a global public health concern, with increasing prevalence and vision loss risk. Myopia typically develops in childhood and progresses more rapidly with earlier onset. Clinical trials exploring treatments for decelerating myopia progression are underway. In Japan, 0.025% atropine ophthalmic solution (RYJUSEA®) has been approved. This review outlines the evaluation process by the Pharmaceuticals and Medical Devices Agency (PMDA) and highlights challenges for future drug development.

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药品和医疗器械管理局对儿童近视药物开发的看法。

病理性近视是全球关注的公共卫生问题，其患病率和视力丧失风险不断增加。近视通常发生在儿童时期，发病越早，进展越快。临床试验正在探索减缓近视进展的治疗方法。在日本，0.025%阿托品眼液（RYJUSEA®）已获批。这篇综述概述了药品和医疗器械管理局（PMDA）的评估过程，并强调了未来药物开发的挑战。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.