• Dr. Quezada-Ruiz, an internationally recognized ophthalmologist and experienced drug development leader, has joined the company as Chief Medical Officer.
  
• Seemi Khan, M.D., M.P.H., M.B.A., has been appointed to the newly created role of Chief Development and Strategy Officer.
  
• Alkeus is accelerating preparations for its global Phase 3 registrational study of gildeuretinol in people living with advanced Stargardt disease.
  

CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, announced today that renowned ophthalmologist, retina specialist and drug development leader Carlos Quezada-Ruiz, M.D., F.A.S.R.S., has joined the company as Chief Medical Officer reporting to the President and Chief Executive Officer and serving on the leadership team. He succeeds Seemi Khan, M.D., M.P.H., M.B.A., who has been appointed to the role of Chief Development and Strategy Officer.

“Dr. Quezada-Ruiz has extensive experience and a strong track record as a cross-functional leader bringing forward groundbreaking therapies that have helped transform the field of modern ophthalmology, and we are very excited to have him join our leadership team,” said Michel Dahan, President and Chief Executive Officer of Alkeus Pharmaceuticals. “His strategic vision, profound clinical insight and passion for evidence-based innovation in ophthalmology will help us unlock the full potential of breakthrough-designated gildeuretinol as he leads Alkeus’ clinical research and development into the future.”

With the expansion of its leadership team, Alkeus is well positioned to realize the full potential of gildeuretinol as a potential standard-of-care, oral therapy for Stargardt disease, if approved. The company continues to rapidly progress preparations for a global Phase 3 study of gildeuretinol in Stargardt disease, which builds on the TEASE clinical program.

“There is a significant unmet need for safe, effective, and convenient treatment options that can help preserve vision for people living with Stargardt disease. As a practicing retina specialist, I have seen firsthand the impact of progressive vision loss and the suffering it causes for patients with Stargardt disease and their families,” Dr. Quezada-Ruiz said. “I am honored to join Alkeus at this moment as we advance toward the launch of a global Phase 3 registrational trial in Stargardt disease. The clinical data we have seen to date are highly encouraging. I look forward to partnering with this dedicated and talented team to advance gildeuretinol, an investigational oral therapy designed to target a primary driver of ABCA4-related retinal degeneration, with the goal of helping preserve retinal structure and stabilize visual function for people living with this inherited condition around the world.”

Prior to joining Alkeus, Dr. Quezada-Ruiz served as Senior Vice President and Ophthalmology Therapeutic Area Head at 4D Molecular Therapeutics (4DMT), where he directed early- and late-stage gene-therapy programs for inherited and neovascular retinal diseases and led trial design and global regulatory alignment for the company’s lead candidate. Previously, Dr. Quezada-Ruiz also held senior leadership positions at Genentech/Roche, where he played a pivotal role in the global development and regulatory approvals of treatments for neovascular (wet) AMD, diabetic macular edema (DME) and diabetic retinopathy (DR). Dr. Quezada-Ruiz has authored numerous scientific publications and lectures, and serves as Assistant Professor of Ophthalmology at the Instituto de Oftalmología Fundación Conde de Valenciana in Mexico City and as Chairman of the Scientific Committee of the Mexican Retina Society. He also serves as a scientific advisor to selected biotechnology companies advancing novel therapies and technologies for retinal diseases.

“Alkeus Pharmaceuticals has made significant strides in innovative approaches to target a key mechanism underlying Stargardt disease, and the appointment of an internationally recognized expert like Dr. Quezada-Ruiz underscores the company’s long-term, strong commitment to the retina community,” said Philip J. Ferrone, M.D., Vitreoretinal Consultants of New York. “Dr. Quezada-Ruiz brings a combination of clinical rigor and deep understanding of inherited retinal diseases that will be invaluable to Alkeus.”

Dr. Khan, who served as Chief Medical Officer since the beginning of 2024 and built the clinical foundation and development plans for the company, has been appointed to the newly created role of Chief Development and Strategy Officer. Dr. Khan will report to Alkeus’ President and Chief Executive Officer, and she will continue to serve on the leadership team.

“Since joining Alkeus two years ago, Dr. Khan has played an instrumental role in the transformation of Alkeus and in the development of our clinical and regulatory plans. Thanks to her dedication and accomplishments, Alkeus is in a position to advance gildeuretinol into Phase 3 and is a step closer to bringing a much-needed therapy for the community of individuals living with Stargardt disease,” Dahan said. “We are thrilled to continue to benefit from her experience and leadership as we embark on the next chapter of growth for our company, driven by our purpose to preserve the sight of individuals impacted by retinal diseases.”

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), currently is being evaluated in clinical trials for the treatment of Stargardt disease.

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 has been studied for geographic atrophy secondary to age-related macular degeneration. Gildeuretinol has received Breakthrough Therapy, Rare Pediatric Disease, Fast Track and Orphan Drug designations for Stargardt disease from the U.S. Food and Drug Administration (FDA). The European Medicines Agency (EMA) has designated gildeuretinol as an orphan medicinal product for the treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene, which includes Stargardt disease.

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 (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 patients with advanced Stargardt disease. The TEASE-2 trial was a randomized, double-masked, placebo-controlled trial in patients with moderate Stargardt disease. TEASE-1 and TEASE-2 have been completed. TEASE-3 (NCT02402660), an ongoing clinical trial in early-stage Stargardt disease, is an 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 (NCT04239625) is an open-label extension study.

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