Alkeus Pharmaceuticals Announces Gildeuretinol Data Presentations During the American Society of Retina Specialists (ASRS) 43rd Annual Meeting July 29-August 2

CAMBRIDGE, Mass., July 23, 2025 (GLOBE NEWSWIRE) — Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that data from its clinical studies of investigational oral gildeuretinol for the treatment of Stargardt disease (TEASE) and for geographic atrophy secondary to age-related macular degeneration (SAGA) will be presented during the American Society of Retina Specialists (ASRS) 43rd Annual Scientific Meeting being held July 29 to Aug. 2, 2025, in Long Beach, Calif.

Oral Presentation:

• Oral Gildeuretinol Slows Disease Progression in Early Stargardt Disease: Updates From the TEASE-3 Study
  Date: Aug. 1, 2025
  Session: Hereditary Retinal Disease & Genetics Symposium 1
  Time: 4:53 p.m. – 4:56 p.m.
  Location: Hall B, Long Beach Convention Center
  Presenter: Kenneth Fan, M.D., M.B.A., Retina Consultants of Texas

Paper on Demand (Recorded Video Presentation)

• Safety Profile of Oral Gildeuretinol Acetate: Safety Results Across TEASE-1, TEASE-3, and SAGA Clinical Studies
  Date: Available on demand for meeting registrants
  Presenter: Mathew MacCumber, M.D., Ph.D., FASRS, Illinois Retina Associates

About Alkeus Pharmaceuticals

Alkeus Pharmaceuticals, Inc. is a private biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases. Based in Cambridge, Mass., Alkeus is backed by institutional investors led by Bain Capital Life Sciences. Alkeus is developing therapies for serious diseases of the eye with high unmet need. Alkeus’ breakthrough-designated lead candidate, gildeuretinol acetate (ALK-001), is a new molecular entity being evaluated in clinical trials for the treatment of Stargardt disease and for geographic atrophy secondary to age-related macular degeneration.

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 U.S. 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.

For further information, contact:

Media@alkeuspharma.com
Website: www.alkeuspharma.com