The World Society of Paediatric Ophthalmology and Strabismus (WSPOS) has formally recognized low-dose atropine eye drops as a safe, evidence-based, and effective intervention for slowing the progression of myopia in children, and is supporting approval of the drops in the United States. WSPOS released a consensus statement expressing support this week. 

According to WSPOS, this position is supported by Level 1 evidence derived from multiple high-quality clinical trials, reinforcing the role of low-dose atropine in myopia management.

"While variability in efficacy has been reported—largely attributable to differences in formulation quality, variable concentration of atropine, population characteristics, and study design—the collective body of evidence supports low-dose atropine as an important component of a comprehensive myopia-control strategy," the statement read. 

WSPOS pointed out that commercially manufactured low-dose atropine eye drops are now available and utilized in many parts of the world, including the United Kingdom, the European Union, Singapore, Japan, China, India, Hong Kong, Colombia, Chile, Peru, Mexico, Kenya (imported) and Australia. These regions have established regulatory-approved production pathways that ensure predictable dosing, product stability, and safety.

However, North America along with much of Africa, remain without a regulatory-approved commercial formulation and continue to rely on compounded preparations, which are inherently more variable.

The WSPOS statement follows a similar statement of support from the The American Academy of Orthokeratology and Myopia Control (AAOMC). 

The latest statement of support comes about 6 weeks after the FDA issued a complete response letter (CRL) for Sydnexis' new drug application (NDA) for SYD-101, a proprietary 0.01% atropine formulation designed to slow the progression of myopia in children. The NDA for SYD-101 was supported by data from the phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial, which the company's calls the largest global clinical study ever conducted in pediatric myopia. The trial enrolled over 800 children aged 3 to 14 years at treatment initiation.

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). A key secondary endpoint—annual myopia progression rate—also achieved statistical significance at 12, 24, and 36 months. 

While the FDA acknowledged that the primary endpoint was met, the agency stated in its CRL that it did not consider the data sufficient to support the effectiveness of low-dose atropine in children with myopia. The letter cited no deficiencies related to safety or product quality.

Sydnexis said at the time that it was committed to working with the FDA to address the items outlined in the CRL and determining the best path forward. In June 2025, the European Commission (EC) granted marketing authorization for SYD-101, marketed under the brand name Ryjunea, making it the the first and only approved pharmaceutical treatment option to treat myopia progression in EU countries. In November, Sydnexis announced that its partner Santen received UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for Ryjunea (low-dose atropine 0.1 mg/mL).