Stuart Therapeutics has submitted an investigational new drug (IND) application amendment to the US Food and Drug Administration (FDA) to investigate its lead candidate, ST-100 (vezocolmitide), as a potential treatment for corneal wound healing.
The planned proof-of-concept study represents the company's first expansion beyond dry eye disease (DED), with the aim of evaluating whether ST-100 can support epithelial and stromal repair following corneal injury.
ST-100 is a collagen mimetic peptide developed using Stuart's proprietary PolyCol™ technology platform. Unlike conventional approaches that primarily support the eye's natural healing processes, the investigational therapy is designed to selectively target and repair damaged helical collagen within the ocular extracellular matrix.
The company intends to follow the initial study with a phase 2 trial in the second half of 2027, assessing ST-100 in several types of corneal wounds, including those resulting from surgery, trauma, ulcers and chemical burns.
“Expanding ST-100 beyond dry eye disease into corneal wound healing has the potential to give physicians an important new tool for treating ocular surface damage,” said Eric Schlumpf, president and CEO of Stuart Therapeutics. “We believe ST-100 is capable of repairing ocular helical collagen damaged by trauma, surgery and chemical burns, a need no currently approved therapeutic directly addresses. If our clinical program bears this out, ST-100 could become a topical therapy for a broad range of ocular surface conditions.”
The announcement follows encouraging findings from earlier clinical investigations of ST-100 in DED. Across phase 2 and initial phase 3 studies involving more than 250 patients, the company reported improvements in corneal fluorescein staining and several symptom-related outcomes, with some benefits observed as early as two days after treatment.
However, the initial phase 3 trial, in June 2025, did not meet its primary endpoint of a statistically significant improvement in Schirmer's tear test responder rates compared with vehicle. The company is now planning another phase 3 registration trial for DED in early 2027.
Eric Donnenfeld, clinical professor of ophthalmology at New York University and a cornea, laser cataract and refractive surgeon at OCLI Vision, highlighted the potential clinical significance of the new program.
“Corneal wounds from a variety of sources, including trauma, surgery and recurrent corneal erosion, remain among the most frustrating problems we manage,” he said in a recent press release. “Our current options support the eye while it heals itself, but nothing addresses the damaged helical collagen structure that underlies these problems or offers a true acceleration of the healing process. A therapy designed to repair that structure directly could give us something we don’t have today: a way to improve healing times and address patient symptoms, not just protect the eye.”
Although ST-100's efficacy in corneal wound healing remains to be established, the proposed studies could help determine whether directly targeting damaged collagen offers a new therapeutic approach to ocular surface repair.
Source: Stuart Therapeutics.
