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Gildeuretinol acetate demonstrated less loss in ellipsoid zone (EZ) area compared to historical sibling controls.
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Early-stage Stargardt disease patients treated with gildeuretinol for two to seven years exhibited relatively stable disease over the course therapy.
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Gildeuretinol was well tolerated and had a safety profile consistent with prior gildeuretinol studies, with the majority of adverse events being mild or moderate.
CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) — Alkeus Pharmaceuticals, Inc. today announced the presentation of an interim data update from its TEASE-3 study demonstrating that five early-stage Stargardt disease patients treated with investigational oral gildeuretinol acetate experienced less loss in ellipsoid zone (EZ) area compared to historical sibling controls and overall disease remained relatively stable while on therapy ranging between two to seven years. The study update was presented during the 43rd American Society of Retina Specialists (ASRS) Annual Scientific Meeting, held July 30 – Aug. 2 in Long Beach, Calif.
“We are encouraged by this new interim data from the TEASE-3 study of gildeuretinol in early-stage Stargardt patients with confirmed disease-causing ABCA4 genetic mutations,” said Seemi Khan, M.D., M.P.H., M.B.A., Chief Medical Officer of Alkeus Pharmaceuticals. “These additional data further support the potential of investigational gildeuretinol to slow disease progression and stabilize vision in individuals living with Stargardt disease. We are excited to continue advancing our efforts towards delivering a treatment for Stargardt disease.”
TEASE-3, the first clinical trial in early-stage Stargardt disease, is an open-label study of gildeuretinol in genetically confirmed patients who exhibit early retinal changes on imaging but have not yet developed meaningful symptoms of vision loss. TEASE-3 study participants each have a sibling who was previously diagnosed with Stargardt disease.
The disease progression over two years is assessed by retinal imaging and functional outcome measures. After the initial two-year treatment period, patients continue to receive gildeuretinol while enrolled in an open label long-term extension study. In the TEASE-3 study, five patients have completed two years of treatment with once-daily oral gildeuretinol.
Gildeuretinol was well tolerated and demonstrated a safety profile consistent with prior gildeuretinol studies, with the majority of adverse events being mild or moderate in severity.
“Time is of the essence for patients losing vision from early-onset Stargardt disease,” said Kenneth Fan, M.D., M.B.A., Retina Consultants of Texas. “With no approved treatments available, these data inform our understanding of retinal health in early-stage disease and underscore the importance of ongoing clinical evaluation.”