FDA Rejection for Low-Dose Atropine Formulation
November 18, 2025
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2 min
Sydnexis, a biopharmaceutical company, received a complete response letter from the FDA regarding its new drug application for SYD-101, a pediatric progressive myopia treatment using a 0.01% atropine formulation. This treatment aims to slow myopia progression in children aged 3–14 and was supported by promising phase III data from the STAR trial, involving 847 children. Although the European Medicines Agency granted a positive opinion, the FDA questions the efficacy of low-dose atropine despite acknowledging safety and endpoint achievement. Sydnexis is determined to collaborate with the FDA to resolve the associated issues.
1. Sydnexis received a CRL from the FDA for SYD-101. 2. SYD-101 is a 0.01% atropine formulation for pediatric myopia. 3. Target age group is 3-14 years. 4. Supported by STAR trial with 847 children. 5. EMA granted positive opinion based on same trial data. 6. FDA questions efficacy despite meeting safety and endpoint criteria. 7. Sydnexis aims to work with FDA for approval resolution.
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