Belite Bio Inc., a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its drug Tinlarebant, intended for the treatment of Stargardt disease (STGD1). This designation follows interim analysis results from the ongoing Phase 3 DRAGON trial, which demonstrated Tinlarebant's efficacy and favorable safety profile. The trial is expected to be completed by the fourth quarter of 2025, including a three-month follow-up period. The drug has previously received Fast Track and Rare Pediatric Disease Designations in the U.S., as well as Orphan Drug Designation in the U.S., Europe, and Japan. Tinlarebant targets retinol binding protein 4 (RBP4) to reduce the accumulation of cytotoxic byproducts of vitamin A, aiming to slow or halt the disease process in STGD1 patients. Currently, there are no approved treatments for this condition.