First patient enrolled in Phase 2 study evaluating therapeutic for persistent corneal epithelial defects

Kiora Pharmaceuticals Inc. this week announced enrolling the first patient as a part of a Phase 2 study evaluating KIO-201 topical eye drops in patients with Persistent Corneal Epithelial Defect (PCED), a rare ocular surface condition characterized by non-healing wounds on the eye surface.

According to Brian M. Strem, PhD, president and CEO of Kiora, said in a news release that the company believes KIO-201 has the potential to address a rare ophthalmic condition in patients who have limited effective treatment options.¹

"Our KIO-201 asset has an extensive portfolio of clinical data demonstrating its ability to improve healing in difficult-to-treat corneal wounds,” he said in a statement. “Promising results from this study will support our efforts to advance KIO-201 to a potential registration study."

According to the company, the trial is designed as a single-arm, open label ten patient (up to 20 eyes) study. Patients will be evaluated at 28 days after receiving KIO-201 six times daily. The endpoints include safety and tolerability︎, as well as the percentage of patients with corneal healing and the associated time to healing.

The company also noted that KIO-201 is a chemically modified form of the natural polymer hyaluronic acid, designed to accelerate natural corneal wound healing. It is formulated as a convenient eye drop and provides a thin coating to the surface of the eye, serving as a protectant to facilitate and accelerate corneal re-epithelization. The chemical modifications enable enhanced viscoelastic properties and a longer ocular surface resonance time compared to standard hyaluronic acid.

The company noted that it is exploring KIO-201 as a treatment for PCED, a condition characterized by an inability of the cornea to properly repair the protective epithelial surface of the eye. This can be due to a variety of factors including physical trauma, surgical injury, infections or inflammatory ocular diseases. It is estimated that there are fewer than 200,000 patients diagnosed annually in the United States with PCED.1

Reference:

1 Vaidyanathan U, Hopping GC, Liu HY, et al. Persistent Corneal Epithelial Defects: A Review Article. Med Hypothesis Discov Innov Ophthalmol. 2019;8(3):163-176.