Belite Bio reported positive top-line results from the global Phase 3 DRAGON trial: oral tinlarebant met its primary endpoint in adolescents with Stargardt disease type 1, showing a statistically significant reduction in the growth rate of retinal lesions. The company said it will pursue regulatory filings, including in the U.S. The readout represents the first pivotal success in STGD1 and positions Belite to seek approval for the first marketed therapy for the rare retinal disorder. The Phase 3 data showed a clinically meaningful 36% reduction in lesion growth versus placebo in imaging endpoints. Belite’s next steps will be regulatory engagements and filing preparations; commercial and reimbursement planning will begin in parallel given the unmet need and potential first‑in‑class status.