Stuart Therapeutics completes Phase 3 trial of vezocolmitide for treatment of dry eye disease

(Image Credit: AdobeStock/Maria Vitkovska)

Stuart Therapeutics has announced the completion of its Phase 3 clinical trial of its lead therapeutic candidate ST-100 (vezocolmitide) for the treatment of dry eye disease (DED).

The Phase 3 clinical trial is a randomized, double-blind, vehicle-controlled trial investigating the efficacy, safety, and tolerability of ST-100. Patients in the trial were treated with ST-100 or placebo for 1 month, which was followed by a 2-week observation period. The trial was originally initiated in December 2023 in 1 site in the United States and completed at multiple sites in Australia.

ST-100 is a patented formulation comprising vezocolmitide, a collagen mimetic peptide that selectively repairs disease-damaged collagen in the eye. According to the company, in pre-clinical research collagen mimetic peptides induced improvements in cell health and function in epithelial, neuronal, and endothelial cells and tissues containing such cells. In addition, reductions in inflammation and oxidative stress were seen as well.¹

Furthermore, based on results seen in a Phase 2 clinical trial of ST-100, the company states ST-100 appears to provide rapid relief, is comfortable for patients, and provides improvement in tear function within 28 days.¹

Topline data results from the Phase 3 trial are expected in February 2025.

References:

1. Stuart Therapeutics Announces Completion of Phase 3 Dry Eye Disease Clinical Trial. Press Release. Published January 21, 2025. Accessed January 21, 2025. https://www.prnewswire.com/news-releases/stuart-therapeutics-announces-completion-of-phase-3-dry-eye-disease-clinical-trial-302356477.html