Alkeus Pharmaceuticals to present TEASE and SAGA study data at ASRS 2025

Author(s):

Key Takeaways

Gildeuretinol acetate (ALK-001) aims to reduce vitamin A dimerization without affecting the visual cycle, targeting Stargardt disease and geographic atrophy.
The TEASE program includes four studies, with TEASE-3 focusing on early-stage Stargardt disease and TEASE-4 as an open-label extension.
The SAGA study, a 24-month trial, evaluated gildeuretinol's safety and efficacy in geographic atrophy secondary to age-related macular degeneration.
Gildeuretinol has received Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA for Stargardt disease.

Discover groundbreaking findings on oral gildeuretinol's impact on Stargardt disease at the ASRS 43rd Annual Meeting in Long Beach, California.

(Image Credit: AdobeStock/kasto)

Data from the TEASE-3 and SAGA clinical studies of investigational oral gildeuretinol will be presented during the American Society of Retina Specialists (ASRS) 43rd Annual Scientific Meeting being held July 29 through August 2, 2025, in Long Beach, California.

Presentation details

Oral Gildeuretinol Slows Disease Progression in Early Stargardt Disease: Updates From the TEASE-3 Study
- August 1, 2025 at 4:53 pm – 4:56 pm PT (oral presentation)
- Kenneth Fan, MD, MBA, Retina Consultants of Texas
Safety Profile of Oral Gildeuretinol Acetate: Safety Results Across TEASE-1, TEASE-3, and SAGA Clinical Studies
- Available on demand for meeting registrants
- Mathew MacCumber, M.D., Ph.D., FASRS, Illinois Retina Associates

About Gildeuretinol Acetate (ALK-001)

Oral gildeuretinol acetate (ALK-001) is a new molecular entity designed to reduce the dimerization of vitamin A without modulating the visual cycle. Gildeuretinol is being evaluated in clinical trials for the treatment of Stargardt disease and for geographic atrophy secondary to age-related macular degeneration. Gildeuretinol has received Breakthrough Therapy, Fast Track, Orphan Drug and Rare Pediatric Disease designations for Stargardt disease from the US Food and Drug Administration.

About the TEASE program

The Tolerability and Effects of ALK-001 on Stargardt disease (TEASE) studies consist of four independent clinical studies of oral gildeuretinol acetate (ALK-001) in Stargardt disease, denoted as TEASE-1, TEASE-2, TEASE-3 and TEASE-4. The TEASE-1 study was a randomized, double-masked, placebo-controlled trial in 50 patients with advanced Stargardt disease and is complete. The TEASE-2 trial is a randomized, double-masked, placebo-controlled trial in 80 patients with moderate Stargardt disease, expected to read out topline data in 2025. TEASE-3, a clinical trial in early-stage Stargardt disease, is an ongoing open-label study of gildeuretinol in genetically confirmed patients with early signs of disease visible on retinal imaging, but who have not begun experiencing symptoms of vision loss. TEASE-4 is an ongoing open-label extension study.

About the SAGA study

The Study of ALK-001 in GA secondary to age-related macular degeneration (SAGA) was a 24-month, double-masked, randomized, placebo-controlled trial to investigate safety, pharmacokinetics, tolerability and efficacy in 198 patients with geographic atrophy secondary to age-related macular degeneration and is complete.