Shots:
- The US FDA has accepted & granted Priority Review to the NDA for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1), with a PDUFA target date of Feb 12, 2027
- NDA was supported by the P-III (DRAGON) trial assessing tinlarebant vs PBO in STGD1 pts, showing 35.7% reduction in atrophic retinal lesion growth rate, measured as DDAF by fundus autofluorescence imaging
- Tinlarebant is an oral therapy designed to reduce vitamin A-derived toxins (bisretinoids) that drive retinal damage in Stargardt disease & contribute to progression of geographic atrophy, an advanced form of dry AMD
Ref: Globenewswire | Image: Belite Bio | Press Release
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