OKYO Pharma has commenced its Phase II clinical trial of OK-101, a novel treatment for neuropathic corneal pain (NCP), by dosing the first participant. This marks a significant step forward in addressing a condition that currently lacks FDA-approved treatment options.
The Phase II trial is a double-masked, randomized, 12-week, placebo-controlled study specifically designed for patients diagnosed with NCP. The trial aims to enroll 48 patients, with the diagnosis confirmed through confocal microscopy. Pedram Hamrah of Tufts Medical Center is the principal investigator for this single-center study.
OK-101 is a lipid-conjugated chemerin peptide agonist that targets the chemerin receptor (ChemR23), a G-protein coupled receptor found on the eye’s immune cells. These cells play a crucial role in the inflammatory response associated with corneal nerve damage. The drug is delivered via topical administration.
According to OKYO Pharma, OK-101 is the first investigational new drug application (IND) granted by the FDA for treating patients with NCP. Neuropathic corneal pain often arises from conditions such as dry eye disease, surgeries, or infections, significantly impacting patients’ quality of life. Current management strategies offer only partial or temporary relief.
OKYO Pharma CEO Dr. Gary Jacob stated, "We are excited to announce the enrolment of the first patient in our Phase II clinical trial of OK-101. This is a key step forward in our mission to provide relief for patients suffering from neuropathic corneal pain, a chronic condition for which no FDA-approved treatments exist today."
Dr. Jacob added, "OK-101 represents a potential breakthrough in the treatment of this condition, and we remain committed to advancing its development with the goal of delivering a novel therapeutic option to patients in need."
OKYO Pharma received a U.S. patent in August for the use of OK-101 in treating symptoms such as irritated, burning eyes, and blurred vision in patients suffering from Dry Eye Disease (DED).
