OKYO Pharma Limited announced a new agreement with Tufts Medical Center to conduct a 40-patient open-label clinical trial evaluating the efficacy and safety of OK-101 in patients with neuropathic corneal pain ("NCP"). The Investigational New Drug ("IND") application for NCP is planned to be filed in Fourth Quarter of 2023, with study enrollment planned to commence shortly after IND allowance by the FDA. NCP is a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals.

OK-101, a novel and investigational therapeutic developed by OKYO Pharma, offers a promising solution to alleviate the symptoms associated with NCP. The trial is anticipated to take 6-9 months to conduct, and is anticipated to have a minor budgetary impact, with a total cost for the trial, including cost of drug manufacture and formulation for investigational use, amount to under $1 million. NCP remains a major unmet medical need for the ocular community, as there is no FDA-approved drug to treat NCP and this trial provides the opportunity to establish OK-101's potential to treat this condition.

This NCP trial will be led by Pedram Hamrah, MD, Professor and Vice Chair of Research and Academic Programs, Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. Using a mouse model of NCP, pioneered by Dr. Hamrah's laboratory and which is based on the ligation of theocular ciliary nerve, OK-101, administered topically to mice, demonstrated a reduced corneal pain response similar to that of gabapentin administered by intraperitoneal injection (a commonly used oral drug for NCP). These observations demonstrated preclinical ?proof-of-concept?

for the topical administration of OK-101 as a potential non-opioid analgesic for NCP. Current treatments for NCP are limited to short term NSAIDs, steroids, oral gabapentin and, in severe cases, opioids. Side effects and the risk of addiction to opioids are currently serious ongoing causes of concern.

OK-101 is currently in a Phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat dry eye disease. This Phase 2, multi-center, randomized, double?blinded, placebo-controlled study is planned to enroll approximately 240 subjects with DED who will be randomly divided into three cohorts of 80 patients each. The three cohorts are comprised of one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101.

The protocol for the study includes two primary endpoints; and key exploratory and secondary endpoints will be used to inform future studies.