Tarsus plans to purchase Alkeus, developer of emerging Stargardt treatment

Tarsus Pharmaceuticals announced plans to acquire Alkeus Pharmaceuticals, including its emerging oral treatment for Stargardt disease, gildeuretinol (ALK-001), in a deal valued up to $800 million. Stargardt diseaseis the most common form of inherited macular degeneration and is often diagnosed in children or teens. There are no current treatments.

Alkeus brought the potential Stargardt treatment to Phase 3 clinical trials, administering gildeuretinol to the first patient in the NORTHSTAR clinical trial in June 2026. The acquisition by Tarsus means that gildeuretinol is moving onto more solid financial ground as it makes its way to approvals and availability for the Stargardt community.

“With this transaction, gildeuretinol will benefit from Tarsus’ financial strength and complementary capabilities in ophthalmology, to support enrollment of our pivotal NORTHSTAR study and to bring this important therapy to patients as quickly as possible,” said Dr. Carlos Quezada-Ruiz, Chief Medical Officer at Alkeus Pharmaceuticals.

Tarsus is a biopharmaceutical company based in Irvine, CA whose acquisition of Alkeus is another step in its strategy to build a leading eye care company to bring treatments to patients with significant unmet needs, according to the company’s press release. Along with other potential treatments in the pipeline, Tarsus has an FDA-approved drug for a common disease of the eyelid called Demodex blepharitis, and acquired IRX-101, an ocular antiseptic from iRenix Medical, Inc. that is currently in clinical trials.

Gildeuretinol aims to slow retinal cell loss

Stargardt is typically caused by mutations in the ABCA4 gene, which cause toxic byproducts from the processing of vitamin A to build up and damage the retina, leading to vision loss. Gildeuretinol is a modified form of vitamin A that creates less toxic waste build-up compared to the natural form of vitamin A.

The NORTHSTAR clinical trial will determine if gildeuretinol slows down the growth of lesions – areas where retinal cells have been lost – to preserve vision. The two-year clinical trial is enrolling 230 participants between the ages of 8 and 45 who have advanced Stargardt disease, with about 55 planned sites across more than 11 countries. Researchers expect results from the study in the second half of 2029. Information on enrolling can be found at Northstartrial.com. Earlier clinical trials of gildeuretinol showed that the treatmentslowed the growth rate of lesions by about 30%.

In addition to gildeuretinol, there are several potential treatments for Stargardt patientsin various stages of development.