A recurring regulatory pressure point in pediatric myopia continued as FDA advisors weighed data supporting Sydnexis. Despite clinician support and attempts to address benefit signals, the panel backed another trial strategy to establish meaningful efficacy. The discussion specifically focused on atropine-related evidence and whether the sponsor’s dataset demonstrates a clinically relevant reduction in myopia progression in children. The outcome signals a high bar for pediatric ophthalmology endpoints and meaningful benefit. For drug developers, the decision underscores that real-world variability in patient response and the need for clearer effect size quantification remain central for future approvals in this space.