OKYO Pharma has initiated the Phase II trial of OK-101, a treatment for neuropathic corneal pain (NCP), by dosing the first subject.
This marks a significant advancement in addressing a condition that currently lacks Food and Drug Administration (FDA)-approved treatment options.
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OK-101, a lipid-conjugated chemerin peptide agonist, targets the chemerin receptor (ChemR23) 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.
It is said to be the first investigational new drug application (IND) granted by the FDA for treating patients with NCP.
The Phase II double-masked, randomised, 12-week placebo-controlled trial is specifically designed for patients diagnosed with NCP. It will enrol a total of 48 patients, with their condition confirmed via confocal microscopy.
Pedram Hamrah of Tufts Medical Center is leading the single-centre study as principal investigator.
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By GlobalDataOKYO Pharma CEO Dr Gary Jacob said: “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.
“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.”
NCP often stems from dry eye disease, surgeries, or infections, leading to severe impacts on patients’ quality of life. The available management strategies only provide partial or temporary relief.
OKYO Pharma received a US 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).
