Evicenter
P&T meetings

Tinlarebant (LBS-008)

Stargardt disease type 1

Manufacturer
Belite Bio
Regulatory submission
NDA submitted June 2026
Last updated
66 sources

Executive summary

Tinlarebant efficacy and safety

1 evidence topic · 2 sources

Summary

DRAGON randomized 104 participants, with 69 assigned to tinlarebant and 35 to placebo. In the modified full analysis set of 96 participants, annual DDAF lesion growth was 0.38 versus 0.59 mm²/year, a reported reduction of 35.7% with P = 0.0033. Visual-acuity change was minimal in both groups over 24 months. Ocular treatment-emergent adverse events occurred in 53 of 69 participants (76.8%) receiving tinlarebant and 8 of 35 (22.9%) receiving placebo. Four tinlarebant recipients (5.8%) discontinued study drug because of ocular adverse events.