Key Takeaways

  • Stuart Therapeutics submitted an IND amendment to the FDA to investigate ST-100 (vezocolmitide) in corneal wound healing, marking the investigational therapy's first proposed expansion beyond dry eye disease

  • The company plans a proof-of-concept study followed by a phase 2 trial in the second half of 2027 evaluating ST-100 in corneal wounds caused by trauma, surgery, ulcers, and chemical burns

Stuart Therapeutics announced that it has submitted an investigational new drug (IND) application amendment to the FDA to evaluate ST-100 (vezocolmitide), its investigational collagen-repair therapy, in patients with corneal wounds.

The planned proof-of-concept study represents the company's first effort to expand the clinical development of ST-100 beyond dry eye disease. The investigational therapy is designed to selectively repair damaged helical collagen, with the goal of supporting corneal epithelial and stromal healing.

According to the company, the expanded development program could establish ST-100 as a potential treatment for corneal damage associated with trauma, surgery, ulcers, chemical burns, and other causes of ocular surface injury.

ST-100 is being developed as a novel therapeutic approach targeting damaged helical collagen, a structural component of ocular tissues. The planned proof-of-concept study will investigate whether the therapy can support epithelial and stromal repair following corneal injury.

Unlike conventional approaches that primarily protect the ocular surface and support the eye's natural healing processes, ST-100 is intended to act directly on damaged collagen structures. The company believes this mechanism could provide therapeutic benefits across multiple types of corneal wounds, regardless of the underlying cause.

"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 proposed mechanism and potential clinical benefits in corneal wound healing remain investigational and will require confirmation in clinical studies.

Following the initial proof-of-concept study, Stuart Therapeutics plans to initiate a phase 2 clinical trial in the second half of 2027.

The planned trial will evaluate ST-100 across several categories of corneal wounds, including injuries resulting from trauma, ophthalmic surgery, corneal ulcers, and chemical burns. The study is intended to generate additional evidence regarding the therapy's potential to promote ocular surface repair.

According to Stuart Therapeutics, phase 2 and initial phase 3 studies involving more than 250 patients demonstrated clinically meaningful improvements in corneal fluorescein staining, an established measure of ocular surface epithelial damage.

The company also reported improvements in dry eye symptoms compared with vehicle, with treatment effects observed as early as Day 2.

These findings provide the rationale for investigating whether ST-100's proposed collagen-repair mechanism could offer benefits in other ocular surface conditions characterized by tissue damage.

Stuart Therapeutics plans to initiate a phase 3 registration trial of ST-100 for dry eye disease in early 2027, while pursuing the separate corneal wound healing development program.