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Stuart Therapeutics Completes Phase III Trial for Dry Eye Disease Treatment

ST-100 is a novel approach to dry eye based on a collagen mimetic peptide.

Stuart Therapeutics (Florida, United States), a clinical-stage drug platform company, has announced a major milestone in its mission to tackle dry eye disease—the last patient’s final visit in the Phase III study of its lead drug candidate, ST-100 (vezocolmitide), a collagen mimetic peptide (CMP).1 

Topline results are expected in February 2025 for the treatment, which is notable for its unique approach to tackling one of eye care’s most pressing needs—a proven approach for relieving the increasing legions of dry eye sufferers worldwide.

“We are pleased to announce the completion of this important milestone for Stuart Therapeutics and offer our congratulations to our study team,” said Eric Schlumpf, president and CEO of Stuart. 

He also added that the company is advancing the development of this new drug class for treatment of multiple indications in ophthalmology. 

Why is ST-100 so exciting?

Using Stuart’s patented platform technology, dubbed PolyCol, ST-100 represents a new way of thinking about dry eye disease treatment. 

This patented formulation is based on a CMP that selectively repairs damaged collagen in the eye. By restoring the collagen matrix and improving cell signaling, ST-100 addresses critical factors in dry eye disease, such as inflammation, oxidative stress and damage to corneal nerves.

A video on PolyCol and its potential use. Presentation made by Eric Schlumpf, President and CEO of the company, at the 12th annual Ophthalmology Innovation Summit (OIS XII) on December 2-3, 2022.

Preclinical research has suggested that ST-100 improves cell health and function in epithelial, neuronal, and endothelial tissues, delivering multiple benefits to patients.

Results from a previous Phase II clinical trial published in Ophthalmology Science in 2024 highlighted ST-100’s rapid relief of symptoms, improved tear function within 28 days, and patient comfort—all factors that set it apart from currently available treatments.2

About the Phase III trial

The Phase III study was a randomized, double-blind, vehicle-controlled trial designed to assess the performance of ST-100 in treating dry eye disease. Patients received either ST-100 or a placebo over a one-month treatment period, followed by a two-week observation phase. 

The trial, which began in December 2023, started at a single site in the United States before expanding to multiple sites in Australia.

The company has stated that it expects topline readouts as soon as February of this year.

References

  1. Stuart Therapeutics Press Release, Available at: https://finance.yahoo.com/news/stuart-therapeutics-announces-completion-phase-183900917.html Accessed on January 22, 2025.
  2. Baratta RO, Schlumpf E, Del Buono BJ, DeLorey S, Ousler G, Calkins DJ. A Phase 2 Trial to Test Safety and Efficacy of ST-100, a Unique Collagen Mimetic Peptide Ophthalmic Solution for Dry Eye Disease. Ophthalmol Sci. 2023;4(3):100451.

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