FDA accepts Sydnexis’ NDA for SYD-101 in pediatric myopia

Sydnexis, Inc announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for SYD-101, a low-dose atropine formulation aimed at slowing the progression of pediatric myopia. The FDA has set a target action date of October 23, 2025, under the Prescription Drug User Fee Act.

If approved, SYD-101 would become the first pharmaceutical treatment available in the U.S. for managing myopia progression in children. The NDA submission is backed by data from the STAR Study, a Phase 3 clinical trial evaluating the drug’s effectiveness over 3 years. The company hopes this milestone will pave the way for new options to reduce the long-term risks associated with myopia.

Read the full press release here.