Alkeus Pharmaceuticals presented data from its clinical studies of investigational oral gildeuretinol for geographic atrophy secondary to age-related macular degeneration (SAGA) and Stargardt disease (TEASE) at the American Academy of Ophthalmology (AAO) annual meeting in Chicago.
Gildeuretinol in Geographic Atrophy (SAGA Study)
Alexander Melamud, M.D., presented results from the SAGA study, a 2-year, randomized, double-masked, placebo-controlled trial evaluating gildeuretinol in patients with geographic atrophy (GA). The presentation highlighted the efficacy of gildeuretinol in slowing the progression of GA, a leading cause of vision loss in older adults. The study design involved a rigorous assessment of visual function and retinal imaging to quantify the impact of gildeuretinol on GA lesion growth.
Deuterated Vitamin A in Stargardt Disease (TEASE Study)
Christine Nichols Kay, M.D., presented positive data from the TEASE program, which investigates the use of gildeuretinol in Stargardt disease. The presentation focused on how deuterated vitamin A preserves vision in patients with Stargardt disease, a rare inherited retinal disease that causes progressive vision loss. The TEASE study demonstrated the potential of gildeuretinol to slow the progression of Stargardt disease by reducing the formation of toxic vitamin A dimers in the retina.
About Gildeuretinol Acetate (ALK-001)
Gildeuretinol acetate (ALK-001) is an oral investigational therapy designed to reduce the dimerization of vitamin A without modulating the visual cycle. Preclinical studies have shown that gildeuretinol decreases vitamin A dimerization to the normal rate seen in unaffected individuals and prevents retinal degeneration and loss of visual function in animals with Stargardt disease. Gildeuretinol is being studied as a potential treatment for Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Gildeuretinol has received breakthrough therapy designation and orphan drug designation from the U.S. Food and Drug Administration.
