Objective:
To present findings from the phase 3 DRAGON trial on the investigational therapy tinlarebant for Stargardt disease.
Approach:
- Study Design: Phase 3 DRAGON trial evaluating tinlarebant (LBS-008) as an oral treatment for adolescent Stargardt disease.
Key Findings:
- Tinlarebant at 5 mg daily significantly slowed the progression of lesions compared to placebo.
- Positive outcomes were observed in both the study eye and the fellow eye using various outcome measures.
- No significant systemic side effects were reported, and adverse visual phenomena were minimal.
Interpretation:
Conclusion:
Belite Bio has submitted a rolling NDA to the FDA for tinlarebant, potentially marking the first treatment for Stargardt disease.
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