Planned study would be ST-100's first beyond dry eye disease
STUART, Fla.--(BUSINESS WIRE)--Stuart Therapeutics Inc., a late-stage biopharmaceutical company developing a new class of therapeutics designed to treat eye diseases by repairing helical collagen, today announced it has submitted an investigational new drug application amendment to the U.S. Food and Drug Administration to study its lead candidate, ST-100 (vezocolmitide), in corneal wound healing. The planned proof-of-concept study would mark ST-100's first expansion beyond dry eye disease and could extend its potential use to patients with corneal damage, regardless of cause.
The proof-of-concept study will evaluate how ST-100, designed to selectively repair damaged helical collagen, supports epithelial and stromal healing in corneal wounds. Stuart plans to follow the study with a phase 2 trial in the second half of 2027 evaluating ST-100 in several types of corneal wounds, including those caused by trauma, surgery, ulcers and chemical burns. That trial could provide additional evidence of ST-100's potential as a reparative therapy for the damaged ocular surface.
The expansion builds on ST-100's clinical trial results in dry eye disease. In phase 2 and initial phase 3 trials involving more than 250 patients, ST-100 demonstrated clinically meaningful improvement in corneal fluorescein staining, a measure of corneal surface damage, and broad symptom relief compared with vehicle as early as day 2 of treatment.¹ The phase 3 registration trial of ST-100 in dry eye disease is planned for early 2027.
“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.”
“Corneal wounds from a variety of sources, including trauma, surgery and recurrent corneal erosion, remain among the most frustrating problems we manage,” said Dr. Eric Donnenfeld, clinical professor of ophthalmology at New York University and cornea, laser cataract and refractive surgeon at OCLI Vision. “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.”
About Corneal Wounds
Corneal wounds, including ulcers, erosions and traumatic injuries, are among the most common eye conditions treated by eye care professionals. In severe cases, they can lead to permanent vision loss. These wounds affect an estimated 500,000-plus2-7 people in the U.S. each year. Current treatment options range from conservative, supportive measures such as lubricating eye drops and bandage contact lenses to more invasive procedures, including corneal debridement and transplants, but none directly repairs the underlying collagen damage. Because collagen is a main structural component of the cornea and the body replaces it slowly, unrepaired damage can prolong healing and lead to scarring and vision loss.
About Stuart Therapeutics Inc.
Stuart Therapeutics Inc. is a late-stage biopharmaceutical company developing a new class of therapeutics that act on disease-damaged helical collagen in the extracellular matrix of the eye, a target previously beyond the reach of conventional therapies. Stuart's pipeline is based on its proprietary PolyCol™ Collagen Mimetic Peptide (CMP) technology platform, which includes more than 400 CMP sequences applicable across a wide range of ophthalmic indications, including dry eye disease, corneal wound healing, glaucoma, myopia and inherited retinal diseases. Stuart’s lead candidate, ST-100, is a collagen-reparative therapeutic designed to restore ocular surface homeostasis in dry eye disease and corneal wounds. In 2027, Stuart plans to begin a phase 3 registration trial in dry eye disease and advance ST-100 in corneal wound healing through a proof-of-concept study and phase 2 trial. For more information, visit StuartTherapeutics.com.
References:
- 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.
- University of Utah Health, Moran Eye Center. Cataract surgery patient outcomes. https://healthcare.utah.edu/moran/cataract-surgery-patient-outcomes
- Moshirfar M, et al. A literature review of the incidence, management, and prognosis of corneal epithelial-related complications after laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and small incision lenticule extraction (SMILE). Cureus. 2023;15(8):e43926.
- Gurnani B, et al. Neurotrophic keratitis. In: StatPearls. StatPearls Publishing; 2025. Updated March 27, 2025.
- Rabiolo A, et al. Neurotrophic keratitis. EyeWiki. American Academy of Ophthalmology. https://eyewiki.org/Neurotrophic_Keratitis
- Kwon JE, et al. Emerging treatments for persistent corneal epithelial defects. Vision (Basel). 2025;9(2):26.
- Maghsoudlou P, et al. Cornea transplantation. In: StatPearls. StatPearls Publishing; 2024.
Contacts
Media Contact:
Powers & Company
StuartTx@powers-co.com
Investor Contact:
Ami Bavishi or Nick Colangelo
Gilmartin Group LLC
StuartTx@gilmartinir.com
