The AAPOS Myopia Task Force welcomes the FDA's decision to convene an Advisory Committee to further evaluate low-dose atropine for pediatric progressive myopia. We support a rigorous, science-based review process that includes fair-minded clinicians with substantial experience currently treating children with progressive myopia using contemporary myopia-control therapies. Recent public reports indicate that the committee will review evidence related to SYD-101, a proprietary low-dose atropine 0.01% formulation currently under FDA review.
As the FDA considers this emerging treatment category, AAPOS believes several important principles deserve consideration:
- Standardization matters. Currently, low-dose atropine for myopia management in the United States is generally obtained through compounding pharmacies, without an FDA-approved reference standard. An approved product could establish important benchmarks for formulation, manufacturing, stability, and quality.
- Innovation should be encouraged. Establishing a regulatory pathway may facilitate development of additional atropine formulations and concentrations, creating more treatment options for physicians and families.
- Access should improve. Because compounded medications are often not covered by insurance, many families face significant out-of-pocket costs. An FDA-approved therapy may help broaden access for children who could benefit from myopia management.
AAPOS takes no position on any specific regulatory outcome. Rather, we support a timely and transparent review process informed by rigorous science, real-world clinical expertise, and a shared commitment to improving the long-term ocular health of children with progressive myopia.