(PRESS RELEASE) The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) Myopia Task Force acknowledged the U.S. Food and Drug Administration’s decision not to approve SYD-101, an investigational low-dose atropine therapy developed by Sydnexis for the treatment of progressive childhood myopia.
While recognizing the FDA’s rigorous standards for pediatric therapies, AAPOS notes that the SYD-101 STAR trial, which is the largest pediatric myopia study ever conducted enrolling more than 850 children—met its primary endpoint and raised no safety or quality concerns. The task force believes the STAR study dataset demonstrate clinically meaningful outcomes in key patient populations, recognized by both the European Commission (EC) and the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA), which have granted marketing authorization for SYD-101. Dilute atropine has been approved for myopia management in several other countries for many years and has consistently shown strong safety and efficacy.
AAPOS remains committed to supporting treatment options for progressive pediatric myopia that meet the highest standards of safety, efficacy and long-term benefit. The organization emphasizes that the FDA’s decision has important implications for pediatric eye care, myopia-control research and ongoing unmet clinical needs. AAPOS believes there is a strong case for approving pharmaceutical formulations of dilute atropine, such as SYD-101, that may offer improved efficacy, better tolerability, more consistent delivery and increased access for families.
Until SYD-101 or other medical therapies receive U.S. regulatory approval, AAPOS advises clinicians to continue offering evidence-based strategies for myopia management. Families are encouraged to consult pediatric ophthalmologists for individualized guidance. Low-dose atropine (off-label) remains an important component of comprehensive myopia management.
