Core Insights - Belite Bio, Inc. has received acceptance from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for a Conditional Marketing Authorization application for Tinlarebant, aimed at treating Stargardt disease based on interim analysis results from the Phase 3 DRAGON trial [1][3][8] Company Overview - Belite Bio is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease and geographic atrophy in advanced dry age-related macular degeneration [6] - The lead candidate, Tinlarebant, is an oral therapy designed to reduce the accumulation of vitamin A-based toxins in the eye, which are implicated in retinal diseases [5][6] Clinical Trial Details - The Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled study evaluating the safety and efficacy of Tinlarebant in 104 adolescent patients with Stargardt disease across 11 jurisdictions [4] - The primary efficacy endpoint of the trial is the growth rate of atrophic lesions, alongside safety and tolerability assessments [4] Regulatory Progress - The interim analysis results from the DRAGON trial met the criteria for the Conditional Marketing Authorization application, with final topline data expected to be reported in Q4 2025 [3][8] - The company is optimistic about the global submissions and potential approvals based on consistent feedback from major regulatory agencies [2]