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

Conclusions

1 evidence topic · 5 sources

Summary

The reported phase 3 benefit concerns slower retinal lesion growth, not a demonstrated between-group improvement in visual acuity over 24 months. FDA acceptance with Priority Review and a February 12, 2027 target action date represents an application under review, not marketing approval. The sponsor’s March 2027 launch timing remains a forecast.