October 24, 2025
Photo credit: Dreamstime Photos
DEL MAR, Calif. — The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Sydnexis in regards to its SYD-101 atropine formulation for myopia. Sydnexis developed SYD-101, a proprietary 0.01% atropine formulation with enhanced ocular delivery characteristics and room-temperature stability, to slow the progression of pediatric myopia in children.
The STAR Trial
The study met its primary efficacy endpoint of proportion of patients with confirmed progression of -0.75D, which FDA had encouraged the company to use. A key secondary endpoint, annual progression rate, also met statistical significance at 12, 24, and 36 months. Furthermore, in a subgroup of fast progressors [more than -0.50D/yr] at 36 months, SYD-101 demonstrated statistically significant treatment effects of a reduction in progression of more than 50%.
The FDA’s Feedback
In the CRL, the FDA acknowledged that the study met this primary endpoint. However, the letter stated the data do not support the effectiveness of low-dose atropine in children with myopia. The reviewers noted no deficiencies related to safety or product quality.
“While we are surprised and disappointed with this decision, Sydnexis is committed to working with the FDA to address the items outlined in the CRL and determining the best path forward toward approval for SYD-101,” said Perry Sternberg, Chief Executive Officer of Sydnexis.
“Our goal is to provide eye care professionals in the U.S. with the first FDA-approved option to help slow the progression of pediatric myopia, rather than continued reliance on compounded formulations of atropine. We remain confident in our data and the potential of SYD-101 to fill a critical innovation gap and treat the most common eye disease in children.”
