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Alkeus to Present TEASE-2 Trial Results for Gildeuretinol in Stargardt Disease at AAO 2025

topline results for gildeuretinol retina patterns
10/15/2025

Alkeus Pharmaceuticals announced that clinical trial results for its investigational oral therapy gildeuretinol acetate (ALK-001) will be presented at the 129th annual meeting of the American Academy of Ophthalmology (AAO), taking place October 18–21, 2025, in Orlando.

The presentation, titled “Safety and Efficacy of Oral Gildeuretinol in Participants with Intermediate-Stage Stargardt Disease,” will share findings from the TEASE-2 study—a randomized, double-masked, placebo-controlled trial evaluating gildeuretinol in patients with moderate Stargardt disease. The data will be presented during Retina Subspecialty Day on October 18 at 8:23 a.m. EDT, in the “Late Breaking Developments” session. The presenter is Philip J. Ferrone, M.D., of Vitreoretinal Consultants of New York.

Gildeuretinol acetate is a new molecular entity designed to reduce the dimerization of vitamin A without modulating the visual cycle. It is currently being evaluated in clinical trials for Stargardt disease and has also been studied in geographic atrophy secondary to age-related macular degeneration. The therapy has received multiple regulatory designations from the U.S. Food and Drug Administration, including Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug status. It is also designated as an orphan medicinal product by the European Medicines Agency.

TEASE-2 is one of four studies in the company’s clinical development program for Stargardt disease. The TEASE-1 study enrolled patients with advanced disease, while TEASE-3 and TEASE-4 focus on early-stage disease and long-term outcomes, respectively.

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