Sydnexis has announced that the U.S. Food and Drug Administration (FDA) intends to convene an advisory committee meeting to review the company’s New Drug Application (NDA) for SYD-101, an investigational low-dose atropine therapy for pediatric progressive myopia (PPM).
The FDA has not yet announced a meeting date, but the advisory committee is expected to review several aspects of the application, including findings from the Phase 3 STAR clinical trial.
The development follows Sydnexis’ submission of a Formal Dispute Resolution Request after receiving a Complete Response Letter from the FDA in October 2025.
Support for SYD-101
According to the company, the advisory committee meeting will provide an opportunity for public discussion of the clinical evidence supporting SYD-101. Perry Sternberg, chief executive officer of Sydnexis, says the company has requested that practicing pediatric ophthalmologists and optometrists participate in the panel.
“For practicing physicians and those living with PPM, the need for an FDA-approved treatment option is not a theoretical question,” he says. “We believe this meeting provides an important opportunity to have a robust, science-led discussion around the totality of evidence supporting SYD-101 and we look forward to hearing the perspectives of clinicians who treat PPM on a daily basis.”
Phase 3 Trial Results
The Phase 3 STAR study, which evaluated the effectiveness of SYD-101. It enrolled 847 children ages 3 to 14 across the United States and Europe, making it the company’s largest completed clinical trial in pediatric myopia. Participants with myopia ranging from -0.50 D to -6.00 D were randomized to receive either SYD-101 0.01% or a vehicle control.
Sydnexis reports that the study met both its primary efficacy endpoint—the proportion of patients experiencing confirmed progression of -0.75 D—and its key secondary endpoint measuring annual progression rate. The therapy was well tolerated, with no unexpected atropine-related adverse events.
Myopia Awareness and Treatment Landscape
The announcement comes as awareness of pediatric myopia continues to grow. In June, the American Medical Association formally resolved to support the classification of myopia as a disease and to advocate for comprehensive insurance coverage of evidence-based treatments that slow its progression in children.
“Low-dose atropine has generated significant use within the clinical community because its therapeutic advantage has been seen over years of real-world use,” says David G. Hunter, MD, PhD, president of the American Association for Pediatric Ophthalmology and Strabismus and ophthalmologist-in-chief at Boston Children’s Hospital. “However, physicians, parents, and patients would benefit greatly from access to an FDA-approved option supported by consistent manufacturing standards, labeling, and heightened regulatory oversight.”