GlobeNewswire·Sep 3, 2026, 11:10 AM ET

Alkeus Announces Publication in JAMA Ophthalmology of Efficacy and Safety Results from the TEASE-1 Study of Gildeuretinol in Stargardt Disease

Alkeus Pharmaceuticals announced peer-reviewed efficacy & safety results for oral gildeuretinol in Stargardt disease published in JAMA Ophthalmology from the TEASE-1 study.
The TEASE-1 trial met its primary endpoint showing a 21.6% statistically significant reduction in retinal atrophic lesion growth rate versus untreated patients over 24 months.
Sensitivity analyses supported these findings with a 29.3% reduction in lesion growth rate using untransformed lesion area measurements.
Gildeuretinol demonstrated a favorable safety profile with no patient-reported events of dark adaptation delays or night blindness across more than 400 treated patients.
The study involved 50 patients aged 18-60 years with retinal atrophy at baseline in a randomized, double-masked, placebo-controlled design.
Gildeuretinol acetate (ALK-001) is a new molecular entity designed to reduce vitamin A dimerization without modulating the visual cycle.
The drug has received FDA Breakthrough Therapy, Fast Track, Orphan Drug, & Rare Pediatric Disease designations for Stargardt disease.
Alkeus is actively enrolling the Phase 3 NORTHSTAR study for gildeuretinol with a target of 230 participants aged 8-45 years.
Tarsus Pharmaceuticals announced a definitive agreement on August 6, 2026, to acquire Alkeus Pharmaceuticals with closing expected in 2026.