Stuart Therapeutics has announced the completion of its Phase 3 clinical trial evaluating ST-100 (vezocolmitide) for the treatment of Dry Eye Disease (DED). The study, a randomized, double-blind, vehicle-controlled trial, assessed the efficacy, safety, and tolerability of ST-100 in patients with DED. Topline data is anticipated in February 2025.
The Phase 3 trial, initiated in December 2023, involved a one-month treatment period with ST-100 or placebo, followed by a two-week observation period. The trial was conducted across multiple sites in Australia, building upon initial work at a single site in the United States.
ST-100: A Novel Approach to Dry Eye Disease
ST-100 (vezocolmitide) is a patented formulation containing a collagen mimetic peptide designed to selectively repair damaged collagen in the eye. This mechanism aims to restore the collagen matrix and facilitate homeostatic cell signaling. Preclinical research suggests that collagen mimetic peptides can improve cell health and function in epithelial, neuronal, and endothelial cells, while also reducing inflammation and oxidative stress – key factors in DED.
Potential Benefits and Previous Findings
According to Stuart Therapeutics, results from a Phase 2 clinical trial indicated that ST-100 provides rapid relief, is well-tolerated, and improves tear function within 28 days. Eric Schlumpf, President & CEO of Stuart Therapeutics, expressed enthusiasm for the completion of this milestone and the potential of ST-100 as a new drug class for various ophthalmic indications.
Dry Eye Disease: An Unmet Need
Dry Eye Disease is a multifactorial ocular disorder affecting millions worldwide. It involves ocular surface damage, inflammation, and corneal nerve damage, leading to discomfort, blurred vision, and difficulties in daily activities. Current treatments often fall short of providing complete relief, highlighting the need for novel therapies like ST-100.
Stuart Therapeutics is a clinical-stage drug platform company focused on developing therapies for ophthalmic diseases, including Dry Eye Disease, Glaucoma, Myopia, and Retinal Diseases, such as Diabetic Macular Edema. The company specializes in therapeutics targeting the extracellular matrix.
