OKYO Pharma Plans to Initiate Phase 2 Trial of OK-101 in Neuropathic Corneal Pain (“NCP”) Following Announcement of Clinical Trial Agreement with Tufts Medical Center

• OKYO plans a 40-patient OK-101 open-label clinical trial with Dr Pedram Hamrah, Tufts Medical Center, as Principal Investigator, a leading expert in treating patients with NCP
• Second clinical indication for OK-101 which is currently in 240 patient phase 2 clinical trial to treat dry eye disease, with top-line data anticipated by end of 2023
• NCP trial anticipated to start in Q4 2023
  

LONDON and NEW YORK, July 28, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat dry eye disease (“DED”) to address the significant unmet need in this multi-billion-dollar market, is pleased to announce 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 Q4 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 open-label trial will provide an opportunity to evaluate the safety and efficacy of OK-101 in a real-world clinical setting, fostering a better understanding of its potential benefits for patients.

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, amounting 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. An ophthalmologist and a clinician-scientist, Dr. Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is a member of OKYO’s Scientific Advisory Board and plans to serve as Principal Investigator of the study, which will be conducted at Tufts Medical Center. This collaborative effort is focused on evaluating OK-101 as a potential non-opioid analgesic to reduce neuropathic corneal pain, a major unmet medical need.