US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025

Sydnexis, of Del Mar, California, reported March 11 that the US FDA had accepted its new drug application for SYD-101, a low-dose atropine eye drop to slow the progression of pediatric myopia.

The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of Oct. 23, 2025.

Sydnexis has said that SYD-101, dosed once-daily at bedtime, is designed for maximum efficacy and comfort, along with three-year stability at room temperature, in contrast with the drawbacks of compounded atropine.