Shots:
- Belite Bio has reported 1yr. interim data from P-III (DRAGON) trial assessing tinlarebant vs PBO in adolescent stargardt disease pts (n=104). Completion expected in Q4’25 with DSMB recommending data submission for regulatory review
- The global Phase III trial utilized an adaptive sample size re-estimation design to evaluate atrophic lesion growth rate, safety & tolerability as 1EPs. However, the DSMB recommended proceeding with the current sample size after interim analysis
- Study showed stable visual acuity (<3 letter change) under both standard & low luminance over 2yrs., with favorable safety & tolerability
Ref: Globenewswire | Image: Belite Bio
Related News:- Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025
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