Belite Bio Inc (NASDAQ: BLTE) completed its rolling submission of a New Drug Application to the U.S. Food and Drug Administration for tinlarebant, an oral therapy for Stargardt disease type 1, according to a company statement.

The submission, initiated in April 2026, was filed under Breakthrough Therapy Designation. Stargardt disease type 1 is a rare inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive vision loss. The condition affects an estimated 53,000 people in the U.S., with no currently approved treatments available.

The completed application will undergo a 60-day FDA review period. If accepted, the agency will assign a Prescription Drug User Fee Act target action date for its decision.

Tinlarebant is designed to reduce accumulation of vitamin A-based toxins called bisretinoids that cause retinal disease. The drug works by reducing levels of serum retinol binding protein 4, which carries vitamin A from the liver to the eye.

The drug has received multiple FDA designations including Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations. It also holds Orphan Drug Designation in the U.S., Europe, Japan, and Switzerland, plus Sakigake Designation in Japan.

Belite Bio previously completed a Phase 3 trial called DRAGON in patients with Stargardt disease type 1, which met its primary endpoint. The company stated the trial demonstrated tinlarebant's ability to reduce the growth rate of retinal lesions compared to placebo.

The San Diego-based clinical-stage company focuses on developing treatments for degenerative retinal diseases. Tinlarebant is currently being evaluated in additional trials for Stargardt disease and geographic atrophy in advanced dry age-related macular degeneration.