Key Takeaways

  • New Phase 3 STAR trial subgroup data will highlight SYD-101’s effects in children with fast-progressing myopia
  • Presentation at ARVO 2026 underscores growing clinical interest in targeted interventions for pediatric myopia progression
  • SYD-101’s formulation features—enhanced permeability, long-term stability, and near-neutral pH—aim to improve both efficacy and patient tolerability

Sydnexis announced it will present new clinical data from a prespecified subgroup analysis of its phase 3 STAR trial evaluating SYD-101, a novel low-dose atropine formulation for pediatric progressive myopia (PPM).

The data will be shared at the upcoming Association for Research in Vision and Ophthalmology (ARVO) annual meeting, scheduled for May 3-7, 2026, in Denver, Colorado. The presentation will focus specifically on children with fast-progressing myopia, a population at heightened risk for long-term vision complications.

Presentation Details:

  • Title: Treatment Response to a Novel Low-Dose Atropine Formulation (SYD-101) in Children with Fast Progressing Myopia: A Subgroup Analysis from the STAR Study
  • Presentation Number: 5584
  • Presenter: Laura Kirkeby, CO
  • Session: Myopia: Risk Factors, Environment, and Interventions (Session ID: 530)
  • Date/Time: Thursday, May 7, 12:30–12:45 p.m. MT

In October, the FDA has issued a complete response letter (CRL) for Sydnexis' new drug application (NDA) for SYD-101, even though the STAR study met its primary efficacy endpoint, showing a statistically significant reduction in the proportion of patients with confirmed progression of -0.75 diopters (D). The trial enrolled over 800 children aged 3 to 14 years at treatment initiation.

The subgroup analysis to be presented this week aims to provide deeper insight into how SYD-101 performs in patients experiencing rapid myopia progression—an area of significant clinical interest as rates of childhood myopia continue to rise globally.

SYD-101 is Sydnexis’ proprietary low-dose atropine formulation designed to slow the progression of myopia in children. The investigational therapy incorporates several features intended to improve both efficacy and patient experience:

  • Demonstrated enhanced ocular tissue permeability in preclinical animal models compared to other atropine formulations
  • Stability for up to three years at room temperature, supporting ease of storage and distribution
  • Near-neutral pH, which may contribute to improved ocular comfort and a favorable safety profile