July 13, 2026
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DEL MAR, Calif. — The U.S. Food and Drug Administration (FDA) shared that it will be convening an Advisory Committee to review Sydnexis‘ SYD-101 formulation for pediatric progressive myopia (PPM).
While the date for the meeting has not been set, the FDA has indicated that the Advisory Committee will be asked to discuss various aspects of the Sydnexis’ application, including findings from the Phase 3 STAR study. Sydnexis submitted a Formal Dispute Resolution Request (FDRR) to the FDA’s Office of Specialty Medicine (OSM) after receiving a Complete Response Letter (CRL) in October of 2025.
The STAR Trial
The Phase 3 STAR trial is the largest global clinical program completed to date in pediatric myopia. It evaluated a broad population of 847 children aged 3–14 at treatment initiation.
Participants with myopia of -0.50D to -6.00D, with a mean baseline of -2.69D, were enrolled across the U.S. and Europe and randomized (1:1:1) to vehicle (placebo) and SYD-101 0.01%. The study’s primary efficacy endpoint was the proportion of patients with confirmed progression of -0.75D, and a key secondary endpoint was annual progression rate.
SYD-101 0.01% successfully met both the primary endpoint (p=0.0226) and the key secondary endpoint (p<0.001). Additionally, SYD-101 was well tolerated with no unexpected atropine-related adverse events.
“We appreciate the FDA’s decision to quickly convene an Advisory Committee meeting and have requested it include practicing pediatric ophthalmologists and optometrists, as they understand the long-term challenges facing patients and families every day,” said Perry Sternberg, Chief Executive Officer of Sydnexis.
“For practicing physicians and those living with PPM, the need for an FDA-approved treatment option is not a theoretical question. 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.”
Low-Dose Atropine for Myopia
Compounded low-dose atropine, supported by emerging evidence of clinically proven efficacy, is currently used by many U.S. physicians to manage PPM in the absence of an FDA-approved pharmaceutical treatment option. While compounded atropine has filled a critical gap in care, compounded products do not undergo the FDA review process for safety, effectiveness, manufacturing consistency and labeling. Low-dose atropine does not have the same post-marketing surveillance requirements as an approved prescription medicine.
Access to compounded therapies can also vary based on factors such as proximity to a compounding pharmacy and the ability to pay for a prescription out-of-pocket, creating additional barriers for children in need of treatment. In June 2026, 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 become an essential tool for many pediatric ophthalmologists managing children with progressive myopia,” said David G. Hunter, MD, PhD, President of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) and Ophthalmologist-in-Chief at Boston Children’s Hospital.
“For younger children at risk of developing high myopia, treatment options remain extremely limited to help slow progression. Low-dose atropine has generated significant use within the clinical community because its therapeutic advantage has been seen over years of real-world use. 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.”
SYD-101 is currently approved in the European Union and UK, where it is licensed to Santen S.A. and marketed as Ryjunea.
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