Stuart Therapeutics Announces Initial Results of Phase III Clinical Trial for ST-100 (Vezocolmitide) Ophthalmic Solution, a Novel Dry Eye Disease Candidate

PR Newswire
Tuesday, June 24, 2025 at 12:01pm UTC

Stuart Therapeutics Announces Initial Results of Phase III Clinical Trial for ST-100 (Vezocolmitide) Ophthalmic Solution, a Novel Dry Eye Disease Candidate

PR Newswire

STUART, Fla., June 24, 2025

  • Results highlight ST-100's potential for fast-acting healing of ocular surface damage caused by Dry Eye Disease, which affects more than 30 million U.S. adults1
  • Therapeutic effects are extremely rapid, providing relief within 2-4 days of treatment for both signs and symptoms
  • ST-100 is uniquely positioned to address unmet patient needs compared to currently approved treatments 
  • Findings will help guide design of second Phase III study

STUART, Fla., June 24, 2025 /PRNewswire/ -- Stuart Therapeutics, Inc., a clinical-stage drug platform company developing novel therapies for ophthalmic diseases, today announced the initial results of its Phase III clinical trial evaluating ST-100 (vezocolmitide) ophthalmic solution for the treatment of Dry Eye Disease (DED), which affects more than 30 million U.S. 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 II outcome2 but did not reach statistical significance, as vehicle performed better than in the Phase II trial.

On several additional important endpoints commonly used to evaluate DED, ST-100 demonstrated industry leading results. 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 III trial was greater than any reported result for any approved DED therapeutic or product. 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.  

"We are very pleased with the outcome of the trial," said Stuart Therapeutics President and CEO Eric Schlumpf. "While additional study is required, the underlying data and the clinically meaningful results from this trial strongly suggest that ST-100, as the first drug candidate in a novel therapeutic class, can address the critical unmet needs in dry eye disease: a fast, effective, and comfortable dry eye topical drop that gives patients rapid relief they can notice and appreciate."

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. Unlike other DED therapeutics, ST-100 works by targeting and repairing damaged collagen. Collagen plays a key role in DED, and collagen damage during the development of DED is part of an inflammatory cycle and loss of tissue integrity that interferes with normal function and cell signaling, particularly in the epithelium of the cornea and conjunctiva. ST-100's ability to repair this ocular collagen restores homeostatic function on the ocular surface, thereby alleviating the effects of DED.

"As a practicing ophthalmologist, I am impressed by the clinical achievements and speed of onset of the therapeutic effects of ST-100 in Stuart's Phase III trial, which suggest rapid ocular surface healing and treatment effects that appear to be considerably greater than those seen with currently approved dry eye disease therapeutics," said Jodi Luchs, MD, Stuart Therapeutics chief medical officer. "Based on these study results, I believe ST-100 has the potential to greatly enhance the treatment of dry eye disease and has significant promise in treating other debilitating diseases affecting the cornea."

Stuart Therapeutics is finalizing a plan for an additional clinical trial using the results from the present Phase III trial to help guide the trial design. The Company also intends to engage with the U.S. Food and Drug Administration (FDA) to confirm the design of this additional trial, and the regulatory path to approval of ST-100.

About Dry Eye Disease
Dry Eye Disease (DED) is a multifactorial ocular disorder suffered by millions of patients worldwide which involves ocular surface damage, inflammation, and damage to corneal nerves, resulting in patient discomfort, blurred vision, and difficulty with activities of daily life.

About ST-100 (Vezocolmitide)
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 These factors are critical in DED and other ophthalmic indications.

About Stuart Therapeutics, Inc.
Headquartered in Stuart, Florida, Stuart Therapeutics, Inc. is a clinical-stage drug platform company addressing DED, Glaucoma, Myopia and Retinal Diseases, such as Diabetic Retinopathy. The company is the leader in the research and development of therapeutics targeting the ocular extracellular matrix.

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.

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