• Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease type 1, having met the primary efficacy endpoint, reduction in lesion growth
  • Presentation to include positive update on secondary endpoints, with quantitative autofluorescence showing a marked divergence between treatment groups
  • New Drug Application to the U.S. Food and Drug Administration for tinlarebant completed

     

SAN DIEGO, July 20, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" or the "Company"), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced additional, positive secondary endpoint data from its Phase 3 DRAGON trial of tinlarebant in Stargardt disease type 1 (STGD1). The findings, along with previously reported topline data, were delivered in an oral presentation at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting on July 18, 2026, in Montréal, Canada.

Notably, the presentation reported that quantitative autofluorescence (qAF), a marker of toxic bisretinoid accumulation, showed a marked divergence between treatment groups. At month 25, in subjects treated with tinlarebant, qAF values remained stable to slightly decreased from baseline (approximately 2%), whereas placebo-treated subjects showed an approximate 20% increase in qAF from baseline. The presentation also provided encore data. As previously announced, the Phase 3 DRAGON trial, which enrolled 104 subjects across 11 jurisdictions worldwide, with a 2:1 randomization (tinlarebant:placebo), met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 35.7% reduction in the growth rate of retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. Tinlarebant was well tolerated throughout the trial.