Belite Bio reported positive top-line results from its Phase III DRAGON study: oral tinlarebant met the primary endpoint by slowing progression of retinal lesions in Stargardt disease type 1. The 104-subject trial showed a statistically significant reduction in lesion growth versus placebo, positioning Belite to pursue regulatory filings in multiple jurisdictions including the U.S. Company statements and clinical summaries indicate tinlarebant reduces serum retinol binding protein 4 to lower toxic vitamin A metabolites in the retina—a mechanism distinct from prior investigational approaches. Belite cited the Phase III outcome as the first successful pivotal study for STGD1 and signaled plans for imminent regulatory interactions. Biotech investors and rare-disease developers will monitor Belite’s planned filings, manufacturing readiness, and payer engagement, given the potential to become the first approved therapy for a pediatric-onset retinal disorder with high unmet need.