Perspective of the Pharmaceuticals and Medical Devices Agency on Drug Development for Childhood Myopia
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.
Authors
- Wataru Asakura
- Kazuhiko Takeuchi (ORCID: https://orcid.org/0000-0001-6855-6425)
- Mitsuru Arima (ORCID: https://orcid.org/0000-0002-6081-8133)
- Atsushi Yoshimura (ORCID: https://orcid.org/0000-0001-9281-9408)
- T Kageyama
- Yosuke Kobayashi (ORCID: https://orcid.org/0000-0003-3959-4347)
- M. Atsumi
- Takumi Aoki (ORCID: https://orcid.org/0000-0002-9788-680X)
- Kazuki Izumi
- Emi Inagaki
Institutions
- Pharmaceuticals and Medical Devices Agency (JP)
Publication Details
- Journal
- Clinical Pharmacology & Therapeutics
- Published
- 2025-10-03
- DOI
- https://doi.org/10.1002/cpt.70086
- Citations
- 1
- Primary Topic
- Ophthalmology and Visual Impairment Studies
- Type
- article
- Field-Weighted Citation Impact
- 1.35