Belite Bio to Present 35.7% Lesion Growth Reduction Data at May 1 Summit
Belite Bio will share Phase 3 DRAGON topline data showing tinlarebant cut atrophic lesion growth by 35.7% versus placebo with strong safety at a May 1 retinal summit. The company began a rolling US FDA submission for tinlarebant in Stargardt disease type 1 in April 2026.
1. Presentation Details
Belite Bio will deliver an oral presentation titled “Topline Results from a 2-year Phase 3 Study of Oral Tinlarebant in Adolescent Patients with Stargardt Disease” at the Retinal Therapeutics Innovation Summit on May 1, 2026 in Denver. Nathan L. Mata, Ph.D., Chief Scientific Officer, will present during the Small Molecules to the Rescue session from 10:55 to 11:10 a.m. MDT.
2. DRAGON Phase 3 Results
The Phase 3 DRAGON trial demonstrated that tinlarebant achieved a 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo over two years while maintaining a strong safety profile in adolescent patients with Stargardt disease type 1.
3. Regulatory Progress
In April 2026, Belite Bio initiated a rolling submission to the US FDA for tinlarebant in STGD1. The therapy holds Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations across regions and is being evaluated in Phase 2/3 DRAGON II and Phase 3 PHOENIX trials.