Stuart Therapeutics Inc. submitted an investigational new drug application amendment to the US Food and Drug Administration (FDA) 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 company said in a press release.

The study will evaluate how ST-100, designed to selectively repair damaged helical collagen, supports epithelial and stromal healing in corneal wounds. Stuart said it 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. The company said that the trial could provide additional evidence of ST-100’s potential as a reparative therapy for the damaged ocular surface.

According to Stuart, 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.

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.