Belite Bio reported positive topline results from the Phase 3 DRAGON trial of tinlarebant in adolescents with Stargardt disease type 1, meeting the primary endpoint with a clinically meaningful reduction in lesion growth versus placebo. The company signalled plans to pursue regulatory filings including submission to the FDA next year. The randomized, 104‑subject study showed a statistically significant slowing of retinal lesion progression measured by fundus autofluorescence. Belite’s oral mechanism lowers serum retinol binding protein 4 to reduce retinal toxic retinoid accumulation. Investors and analysts have taken note; the outcome positions Belite to seek the first approved therapy for a currently untreatable rare retinal disease.