OKYO Pharma to Initiate Neuropathic Corneal Pain Trial for OK-101 Phase 2 randomized, placebo-controlled trial in neuropathic corneal pain (NCP) patients planned to begin in Q3, 2024 OK-101 is believed to be the first IN

Pharma to Initiate Neuropathic Corneal Pain Trial for OK-101

and New York, NY, July 11, 2024 - OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing

innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular

segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy,

announced today its plan to advance OK-101 into a Phase

2 clinical trial of neuropathic corneal pain which is expected to begin in Q3 2024. This one-year study is supported by pre-clinical

animal model data and statistically significant pain relief observed in OK-101's first human trial recently conducted in DED patients.

Phase 2 NCP trial will be conducted at a single-center and will be led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator.

Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, 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 also a member of OKYO's Scientific Advisory Board.

am looking forward to rigorously evaluating OK-101's potential in treating pain symptoms in patients suffering from neuropathic

corneal pain," said Dr. Hamrah. "We have designed an effective protocol to test our hypothesis in this patient population

after productive FDA interactions and we will be closely overseeing the conduct of this trial at Tufts Medical Center."

believe that OK-101 is the first NCP drug candidate to have received FDA IND clearance for clinical evaluation and are pleased to be

making rapid progress to advance the NCP program while working to refine the study design for our upcoming trial in DED," said

Dr. Gary S. Jacob, Ph.D., CEO of OKYO. "The favorable improvements in ocular pain in dry eye patients, a percentage of whom suffer

from NCP, along with the impressive results from a preclinical model of NCP are encouraging signs as we look for a positive result in

this upcoming Phase 2 trial in NCP. Notably, OK-101 targets a receptor found in neurons and glial cells. NCP is an acutely painful ocular

disease with no FDA-approved therapy. We are hoping to deliver an exciting innovation to this ophthalmic unmet need."

Phase 2 NCP study is designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in 48 NCP

patients whose disease has been diagnosed by confocal microscopy. The primary endpoint for the study is pain improvement measured

by VAS compared to placebo. There will be a total of five study visits over the course of 16 weeks, which includes a follow-up visit

four weeks after completion.

a recently completed Phase 2 trial of DED patients, there was a statistically significant and durable improvement in pain, blurred vision,

and burning/stinging as measured by VAS beginning on Day 29, Day 15 and Day 15, respectively, and through the last study visit at Day

85. Additionally, there was a significant improvement in pain scores as measured by patient reported daily diaries observed as early

as within the first two weeks of treatment and through the last study visit at Day 85. Furthermore, in a preclinical mouse model, OK-101

reduced corneal pain response comparably to gabapentin on Day 14 post-surgery. For additional details, please refer to the slides in

the issued Form 6-K filing.

corneal pain (NCP) is a condition that causes pain and sensitivity of the eyes, face, or head. The exact cause of NCP is unknown but

thought to result from nerve damage to the cornea combined with inflammation. NCP, which can exhibit as a severe, chronic, or debilitating

condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments

in an off-label fashion. There are no approved commercial treatments currently available for this condition.

is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of

the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide technology to produce a novel

long-acting drug candidate for treating dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-reducing efficacy

signals in mouse models of dry eye disease and corneal neuropathic pain (NCP), respectively, and is designed to combat washout through

the inclusion of the lipid anchor built into the drug molecule to enhance the residence time of OK-101 within the ocular environment.

OK-101 recently showed statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled

trial of OK-101 to treat DED.

Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of DED

and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel

molecules to treat inflammatory DED and ocular pain. In addition to the recently completed Phase 2 DED trial, OKYO also has plans underway

for the opening of a Phase 2 trial for OK-101 to treat NCP in patients with this debilitating condition. For further information, please

visit www.okyopharma.com.

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identified as "Risk Factors" in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2023. The

Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which

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