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# Belite Bio Files NDA for Stargardt Disease
- URL: https://www.fdaweb.com/belite-bio-files-nda-for-stargardt-disease/
- Published: 2026-08-11T12:00:00.000Z
- Updated: 2026-09-14T13:44:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161610

FDA has accepted for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1 (STGD1). The agency has set a user fee review action target date of 2/12/2027.

The submission was based on data from the Phase 3 DRAGON trial, which demonstrated a statistically significant and clinically meaningful 35.7% reduction in the growth rate of atrophic retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo, according to the company.

Tinlarebant has been generally well tolerated in clinical trials with side effects consistent with its mechanism of action,” it says. “If approved, tinlarebant would be the first ever FDA-approved treatment option for STGD1, a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss and affects an estimated 53,000 people in the U.S. alone.”