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Stuart Therapeutics Reports Initial Results of Phase 3 Trial for ST-100 (Vezocolmitide) Ophthalmic Solution for DED

Results highlight ST-100's potential for fast-acting healing of ocular surface damage caused by dry eye disease.

Ophthalmology Management June 24, 2025

Stuart Therapeutics announced the initial results of its phase 3 clinical trial evaluating ST-100 (vezocolmitide) ophthalmic solution for the treatment of dry eye disease (DED), which affects more than 30 million US adults.1 

The 29-day randomized, double-blind, vehicle-controlled trial assessed a variety of endpoints, including a primary endpoint of a significant increase in the proportion of patients exhibiting a greater than 10mm improvement from baseline in the Schirmer's tear test score (the Schirmer's Responder Rate, or SRR). ST-100's SRR performance exceeded that of its phase 2 outcome2 but did not reach statistical significance, as vehicle performed better than in the phase 2 trial, the company said in a press release. 

In addition, ST-100 achieved statistically significant Week 1 fluorescein staining improvement in multiple regions of the eyes of trial subjects, with onset and clinically meaningful (>20%) improvement on Day 4. The Week 1 magnitude of stain improvement vs vehicle in this phase 3 trial was greater than any reported result for any approved DED therapeutic or product, the company said in the press release. Statistically significant visual function improvement relative to placebo was achieved on Day 2, further reinforcing ST-100's potential to provide fast-acting resolution of dry eye signs and symptoms.  

According to Stuart Therapeutics, ST-100 is part of a novel drug class of collagen mimetic peptides derived from the company's patented and proprietary PolyCol technology platform, which have a unique mechanism of action. ST-100 works by targeting and repairing damaged collagen. ST-100's ability to repair this ocular collagen restores homeostatic function on the ocular surface, thereby alleviating the effects of DED, the company said.

ST-100 is a patented formulation of vezocolmitide, a collagen mimetic peptide that selectively repairs disease-damaged collagen in the eye. This repair of the ocular collagen matrix restores homeostatic cell signaling, particularly in the ocular epithelium. In its preclinical research, Stuart Therapeutics showed that collagen memetic peptides induce improvements in cell health and function in epithelial, neuronal and endothelial cells and tissues containing such cells,3-6 and reductions in inflammation and oxidative stress.7 

Stuart Therapeutics said it is finalizing a plan for an additional clinical trial using the results from the present phase 3 trial to help guide the trial design. The company said it also intends to engage with the US Food and Drug Administration (FDA) to confirm the design of this additional trial, and the regulatory path to approval of ST-100.

References:

  1. McCann, et al. Prevalence and Incidence of Dry Eye and Meibomian Gland Dysfunction in the United States: A Systematic Review and Meta-analysis. JAMA Ophthalmology. 2022 Dec 1;140(12):1181-1192.

  2. Baratta RO, Schlumpf E, Del Buono BJ, DeLorey S, Ousler G, Calkins DJ. A Phase 2 Trial to Test Safety and Efficacy of ST-100, a Unique Collagen Mimetic Peptide Ophthalmic Solution for Dry Eye Disease. Ophthalmol Sci. 2023 Dec 12;4(3):100451. doi: 10.1016/j.xops.2023.100451. PMID: 38317866; PMCID: PMC10838901.

  3. Baratta RO, Del Buono BJ, Schlumpf E, Ceresa BP and Calkins DJ (2021) Collagen Mimetic Peptides Promote Corneal Epithelial Cell Regeneration. Front. Pharmacol. 12:705623, doi: 10.3389/fphar.2021.705623.

  4. McGrady NR, Pasini S, Baratta RO, Del Buono BJ, Schlumpf E and Calkins DJ (2021). Restoring the Extracellular Matrix: A Neuroprotective Role for Collagen Mimetic Peptides in Experimental Glaucoma. Front. Pharmacol. 12:764709, doi: 10.3389/fphar.2021.764709.

  5. Ribeiro, M.; McGrady, N.R.; Baratta, R.O.; Del Buono, B.J.; Schlumpf, E.; Calkins, D.J. Intraocular Delivery of a Collagen Mimetic Peptide Repairs Retinal Ganglion Cell Axons in Chronic and Acute Injury Models (2022). Int. J. Mol. Sci. 23:2911, https://doi.org/10.3390/ijms23062911.

  6. Wareham LK, Holden JM, Bossardet OL, Baratta RO, Del Buono BJ, Schlumpf E and Calkins DJ (2023). Collagen mimetic peptide repair of the corneal nerve bed in a mouse model of dry eye disease. Front. Neurosci. 17:1148950, doi: 10.3389/fnins.2023.1148950.

  7. Ribeiro, M.; Pasini, S.; Baratta, R.O.; Del Buono, B.J.; Schlumpf, E.; Calkins, D.J. (2022). Collagen Mimetic Peptides Promote Adherence and Migration of ARPE-19 Cells While Reducing Inflammatory and Oxidative Stress. Int. J. Mol. Sci. 23:7004, https://doi.org/10.3390/ijms23137004.