Stuart Therapeutics seeks FDA clearance to study ST-100 in corneal wound healing

Stuart Therapeutics Inc. has submitted an investigational new drug application amendment to the FDA to study its lead candidate, ST-100 (vezocolmitide), in corneal wound healing, according to a company press release issued on October 9, 2026. The planned proof-of-concept study would be the first expansion of ST-100 beyond dry eye disease, and it could extend the drug’s potential use to patients with corneal damage of any cause.

Study Plans

The proof-of-concept study will assess how ST-100, which is designed to selectively repair damaged helical collagen, supports epithelial and stromal healing in corneal wounds, the press release explains. After this study, the company plans to begin a phase 2 trial in the second half of 2027. That trial will evaluate ST-100 in several types of corneal wounds, including wounds caused by trauma, surgery, ulcers and chemical burns, and may provide further evidence of the drug’s potential as a reparative therapy for a damaged ocular surface.

Building on dry eye results

The new program is based on ST-100’s clinical results obtained in dry eye disease. In phase 2 and initial phase 3 trials that included more than 250 patients, ST-100 produced clinically meaningful improvement compared with vehicle in corneal fluorescein staining, a measure of corneal surface damage. It also provided broad symptom relief, with effects seen as early as day 2 of treatment.¹ A phase 3 registration trial of ST-100 in dry eye disease is planned for early 2027.

Company and Clinician Perspectives

Eric Schlumpf, president and CEO of Stuart Therapeutics, said the expansion could provide physicians with an important new tool for treating ocular surface damage. “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.”

Eric Donnenfeld, MD, clinical professor of ophthalmology at New York University and a cornea, laser cataract and refractive surgeon at OCLI Vision, described corneal wounds from sources such as trauma, surgery and recurrent corneal erosion as among the most frustrating problems clinicians manage. “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.”

Reference
1. Stuart Therapeutics. Safety and efficacy of ST-100 (vezocolmitide) ophthalmic solution 60 μg/mL in subjects diagnosed with dry eye disease (DED): phase 3 trial. Data on file. https://www.allclinicaltrials.com/study/NCT06178679?searchMetadata=eyJjb25kaXRpb24iOiJkcnktZXllLWRpc2Vhc2UiLCJzZWFyY2hDYXJkUG9zaXRpb24iOjd9