OKYO Pharma Announces First-Patient First-Visit for Phase 2 Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye Disease Trial designed with pre-specified primary efficacy endpoints discussed previousl

Pharma Announces First-Patient First-Visit for Phase 2 Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye Disease

and New York, NY, May 2, 2023 - OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company

which is developing OK-101 to treat dry eye disease to address the significant unmet need in this multi-billion-dollar market, is pleased

to announce that the first patient has been screened for its phase 2, multi-center, randomized, double-blinded, placebo-controlled

trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with dry eye disease (DED).

initiation of this trial of topically applied OK-101 to treat dry eye disease marks a significant step for the company as we have been

laser focused on moving this drug candidate into clinical trials over the last 18 months," said Gary S. Jacob, Ph.D., CEO of OKYO

Pharma. "Importantly, this first clinical study is designed to include pre-specified primary efficacy endpoints which are the hallmark

of phase 3 registration trials, and the results from this trial are anticipated before the end of this year. The drug has been shown

in pre-clinical studies to have potent anti-inflammatory and neuropathic corneal pain activities, and we are eager to evaluate its potential

benefits in the clinic."

of the most exciting aspects of this innovative clinical program is that we can get a rapid and informative answer on both safety and

efficacy of OK-101 by the end of the year," said Gabriele Cerrone, Executive Chairman and Founder of OKYO Pharma. "Furthermore,

positive results would allow us to expedite the program towards FDA approval by leveraging results from this phase 2 dry eye trial in

lieu of one of the two required phase 3 trials needed to support U.S. marketing authorization. OKYO remains well-positioned as novel

ophthalmic compounds in large markets represent promising acquisition targets as evidenced by the recent $5.9 billion Iveric deal."

eye disease is a common condition that occurs when an individual's tears are unable to adequately lubricate the eyes. This condition

affects approximately 49 million people in the U.S. alone and has been a difficult one to positively diagnose and to treat due to the

multifactorial nature of the condition. A number of contributing factors can lead to this condition, including age, sex, certain medical

conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the

the Phase 2 Trial Design

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 3 cohorts of 80 patients. Participants will be selected based on specific inclusion and exclusion

criteria. The three cohorts will be comprised of one cohort treated with placebo, a second cohort treated with a low dose of OK-101,

and the third cohort receiving a higher dose of OK-101. The drug and placebo will be administered in both eyes twice daily for 12 weeks.

The duration of a patient's treatment will be approximately 14 weeks, including a 2-week run-in period and 12 weeks of treatment.

The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Further details regarding

the specifics of the trial are posted on the ClinicalTrials.gov public website (ClinicalTrials.gov Identifier: NCT05759208).

Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences company admitted to listing on NASDAQ and on the standard segment of the

Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange

plc. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain. For

further information, please visit www.okyopharma.com

is a lipid conjugated chemerin peptide antagonist 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 (MAP) 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

activities in mouse models of dry eye disease and corneal neuropathic pain; and is designed to combat washout through the inclusion of

the lipid anchor' contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.

statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather

are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words

such as anticipates,' expects,' intends,' plans,' believes,' seeks,'

estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees

of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's

control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking

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

statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this

announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to

release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events

occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

further information, please visit the Company's website at www.okyopharma.com

person who arranged for the release of this announcement on behalf of the Company was Gary S. Jacob, Ph.D., Chief Executive Officer of