An FDA advisory panel did not recommend a benefit conclusion for Sydnexis based on real-world atropine use signals, instead pointing toward the need for additional clinical evidence of meaningful benefit in pediatric myopia. Biocentury reported that while clinicians have supported approval and atropine use is widespread, the advisors favored continuing trials to establish the required level of benefit. The decision centers on what constitutes “meaningful benefit” for children and how the company’s data support that threshold. The outcome keeps regulatory momentum on track for the sponsor to clarify efficacy or risk-benefit findings in a way that satisfies FDA advisory expectations for pediatric ophthalmic interventions.