Core Insights - Belite Bio, Inc is participating in the Asia-Pacific Academy of Ophthalmology (APAO) 2026 Congress to present findings related to its drug tinlarebant for Stargardt disease type 1 (STGD1) [1][2] Company Overview - Belite Bio is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases, including STGD1 and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD) [8] - The lead candidate, tinlarebant, is designed to reduce the accumulation of bisretinoid toxins in the eye, which are linked to retinal diseases [8] Upcoming Presentations - The company will present topline results from the Phase 3 DRAGON study of tinlarebant for adolescents with STGD1 during the APAO Congress [2][3] - An oral presentation is scheduled for February 6, 2026, and a sponsored lunch symposium will take place on February 7, 2026 [3] Exhibition Details - Belite Bio will have an exhibition booth at the APAO Congress from February 5-7, 2026, located at Hall 5E, Booth 5E-C03 [4] About Tinlarebant - Tinlarebant is an oral therapy that aims to reduce vitamin A-based toxins causing retinal disease in STGD1 and contributes to disease progression in GA [4] - The drug has received multiple designations, including Breakthrough Therapy and Fast Track in the U.S., and Orphan Drug Designation in the U.S., Europe, and Japan [4] About Stargardt Disease Type 1 (STGD1) - STGD1 is the most common inherited macular dystrophy, leading to central vision loss due to mutations in the ABCA4 gene [5] - There are currently no FDA-approved treatments for STGD1, highlighting the unmet medical need in this area [5]

Core Insights - Belite Bio has completed enrollment of 60 subjects in the Phase 2/3 DRAGON II clinical trial for tinlarebant, targeting Stargardt disease type 1 (STGD1) [1][2][7] - The trial is a global, 24-month, randomized, double-masked, placebo-controlled study involving participants aged 12 to 20 years from Japan, the United States, and the United Kingdom [2] - The company plans to submit a New Drug Application (NDA) to the FDA for tinlarebant in the first half of 2026 [3][7] Clinical Trial Details - The DRAGON II trial aims to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1 [2] - Participants are randomized 1:1 to receive either tinlarebant or placebo [2] - The completion of enrollment reflects strong engagement from the Stargardt disease community [3] Drug Information - Tinlarebant is an oral therapy designed to reduce the accumulation of vitamin A-based toxins (bisretinoids) that cause retinal disease in STGD1 [4] - The drug works by modulating serum retinol binding protein 4 (RBP4) levels, thereby reducing bisretinoid formation [4] - Tinlarebant has received multiple designations, including Breakthrough Therapy Designation and Fast Track Designation in the U.S. [4] Company Overview - Belite Bio focuses on developing novel therapeutics for degenerative retinal diseases and specific metabolic diseases [5] - The company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is also evaluating tinlarebant in a Phase 3 trial (PHOENIX) for geographic atrophy [5] - The company is committed to advancing research for adolescents with Stargardt disease globally [3]

Core Insights - Belite Bio, Inc. is focused on developing novel therapeutics for degenerative retinal diseases, specifically targeting Stargardt disease and geographic atrophy, which have significant unmet medical needs [1][5] Group 1: Presentations at ARVO Annual Meeting - The company will present two posters at the ARVO Annual Meeting from May 4-8, 2025, in Salt Lake City, Utah [1] - The first presentation will cover baseline characteristics of adolescent subjects in the Phase 3 DRAGON trial of Tinlarebant [2] - The second presentation will discuss pharmacokinetic and pharmacodynamic properties of Tinlarebant in adolescent Japanese patients [2] Group 2: Tinlarebant Overview - Tinlarebant is an oral therapy designed to reduce the accumulation of vitamin A-based toxins (bisretinoids) that lead to retinal diseases [3] - The drug works by modulating serum retinol binding protein 4 (RBP4) levels, thereby reducing bisretinoid formation [3] - Tinlarebant has received multiple designations, including Fast Track and Orphan Drug Designation in the U.S., and Sakigake Designation in Japan for treating STGD1 [3] Group 3: Stargardt Disease (STGD1) - STGD1 is the most common inherited macular dystrophy, leading to central vision loss due to mutations in the ABCA4 gene [4] - There are currently no FDA-approved treatments for STGD1, highlighting the need for effective therapies [4] - The disease progression is monitored through the accumulation of bisretinoids, which also affects patients with geographic atrophy [4] Group 4: Company Background - Belite Bio is a clinical-stage biopharmaceutical company dedicated to developing therapies for degenerative retinal diseases and specific metabolic diseases [5] - The lead candidate, Tinlarebant, is being evaluated in multiple Phase 3 studies, including DRAGON and PHOENIX, targeting both STGD1 and geographic atrophy [5]