The Safety and Efficacy of SYD-101 in Children With Myopia

Summary

Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

Timeline

Start

2019-04-24

Primary completion

2024-05-02

Completion

2025-05-01

Publications

• Background Johnson P, Widder K, Cheetham J, Kirkeby L. Methods and baseline of a large, multicenter, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study). Invest Ophthalmol Vis Sci. 2025; 66(8), 2825
• Background Cheetham JK, Gieschen L, Kirkeby L, Widder K, Johnson P. The natural history of myopia progression in a large diverse pediatric population. Invest Ophthalmol Vis Sci. 2025; 66(8), 2824
• Korenfeld M, Hurcikova M, Tatsuoka K, Tomcikova D, Cheetham J, Kacerik M; STAR Study Investigators. STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03. Ophthalmol Ther. 2026 May;15(5):1685-1703. doi: 10.1007/s40123-026-01341-0. Epub 2026 Mar 23.

Drugs

Indications