Overview
- The 104-patient, 24-month DRAGON study met its primary endpoint with a 35.7% reduction in lesion-growth rate versus placebo (p=0.0033).
- Statistically significant effects were also seen in the fellow eye and on decreased autofluorescence lesion growth based on imaging analyses.
- Tinlarebant was generally well tolerated, with four treatment-related discontinuations and mostly mild, resolving eye-related side effects.
- The 5 mg dose lowered serum RBP4 by about 80% from baseline, consistent with its mechanism to curb toxic vitamin A byproducts.
- Belite plans regulatory discussions and targets New Drug Application submissions in the first half of 2026, and the stock rose by double digits premarket.