Tarsus Pharmaceuticals said it has agreed to acquire Alkeus Pharmaceuticals, adding the investigational oral retinoid gildeuretinol (formerly ALK-001) and a phase 3 program in Stargardt disease to its expanding ophthalmic pipeline. According to Tarsus, the deal strengthens its presence in retina following its previous acquisition of iRenix Medical.

Gildeuretinol is an investigational oral therapy designed to reduce the accumulation of vitamin A dimers while preserving the normal visual cycle. The drug is being developed for Stargardt disease, an inherited retinal degeneration for which there are no approved treatments. The TEASE clinical program included randomized placebo-controlled studies in advanced (TEASE-1) and moderate (TEASE-2) Stargardt disease, as well as an ongoing open-label study in early-stage disease (TEASE-3) and a long-term extension study (TEASE-4).

Informed by these studies, the phase 3 NORTHSTAR trial is currently enrolling approximately 230 patients with Stargardt disease. The study's primary endpoint is the rate of retinal atrophic lesion growth over 24 months, with change in low-luminance visual acuity as a key secondary endpoint. Tarsus said the study design was developed in consultation with the FDA and the European Medicines Agency, and topline results are expected in the second half of 2029.

Gildeuretinol was previously evaluated in geographic atrophy secondary to age-related macular degeneration in the phase 2 SAGA study, although Tarsus has not announced plans for further development in that indication.

The acquisition has been approved by the boards of directors of both companies and by Alkeus shareholders. The transaction is expected to close later in 2026, subject to regulatory review and customary closing conditions. OM