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Perspective of the Pharmaceuticals and Medical Devices Agency on Drug Development for Childhood Myopia
Mitsuru Arima1, Motomasa Atsumi1, Kumiko Takeuchi1
1Office of New Drug III, Pharmaceuticals and Medical Device Agency, Tokyo, Japan.
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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