Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio announced the completion of its rolling NDA submission to the FDA for tinlarebant, an oral therapy for Stargardt disease type 1 (STGD1), a rare inherited retinal disease affecting approximately 53,000 people in the U.S. with no current approved treatments. The submission was made under Breakthrough Therapy Designation and will undergo a 60-day FDA review period. The Phase 3 DRAGON trial demonstrated tinlarebant's ability to significantly reduce the growth rate of retinal lesions compared to placebo.