FDA advisory discussions on Sydnexis data did not shift despite evidence of widespread atropine use, according to the report. Panelists leaned toward requesting additional trial work to establish meaningful benefit in pediatric myopia, even with clinician support for approval. The outcome highlights a key tension in regulatory review for myopia treatments: real-world prescribing patterns do not always translate into the level of evidence regulators and advisors require to define robust clinical benefit. The panel’s stance points to the need for clearer or more definitive data to support labeling. For companies targeting the pediatric myopia market, the message is direct—regulators are likely to focus on trial-defined benefit thresholds rather than practice-based uptake when advisory committees evaluate endpoints.