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OKYO Pharma Limited (" OKYO ", " OKYO Pharma " or the " Company ") OKYO Pharma Announces Custom Clearance of GMP Packaged OK-101 Drug to be Used in Phase 2 Clinical Trial for Treating Dry Eye Disease London and New York,

Key Takeaway: OKYO Pharma has announced that its GMP packaged OK-101 drug has successfully cleared customs in the U.S., preparing for a Phase 2 clinical trial for dry eye disease (DED). The company is working on generating randomization codes and authorizing clinical sites, with the first patient visit anticipated in Q1 2023 and top-line data expected to be released in Q4 2023. CEO Gary S. Jacob expressed optimism about the trial, emphasizing the drug's potential to introduce new treatment options for DED patients who currently have limited therapies available.

Market Sentiment Analysis

POSITIVE FACTORS

  • OKYO Pharma has cleared customs for its OK-101 drug, moving forward in clinical trial preparations.
  • The upcoming Phase 2 clinical trial is expected to begin in Q1 2023, indicating strong progress.
  • OK-101 aims to address the significant unmet need in the dry eye disease market.

Full Press Release Details

("OKYO", "OKYO Pharma" or the "Company")
OKYO Pharma Announces Custom Clearance of GMP Packaged OK-101 Drug
to be Used in Phase 2 Clinical Trial for Treating Dry Eye Disease
London and New York, NY, February 28, 2023 -
OKYO Pharma Limited (LSE: OKYO; 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, today announced that its GMP packaged
OK-101 drug to be used in the upcoming Phase 2, first-in-human, clinical trial in patients with DED, which was recently shipped from Europe,
has cleared customs in the United States.
OKYO is now in the process of
having randomization codes generated for its double blinded placebo-controlled trial, along with other activities needed for initiating
the trial, including authorization of those clinical sites planned for the Phase 2 clinical trial. Once these activities are completed,
the drug for the study is planned to be shipped to those sites involved in the trial. OKYO is anticipating the first-patient-first visit
in Q1 2023 and looking to release top-line data from this trial in Q4 2023.
"Initiation of the first-in-human Phase 2 trial for OK-101 to
treat DED has been a central and critical goal for the company for the past 18 months," said Gary S. Jacob, Ph.D., CEO of OKYO Pharma
Ltd. "We are excited to be very close now to moving this drug into clinical trials and believe that OK-101 can provide a new way
to treat DED patients who are presently not well-served by currently approved drugs."
OK-101 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 has been
shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively,
and is designed to combat washout through the inclusion of the lipid anchor' contained in the drug molecule to enhance the
residence time of OK-101 within the ocular environment.
Forward-Looking Statements
Certain 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.
For further information, please visit the Company's
The person who arranged for the release of this
announcement on behalf of the Company was Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO.
OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer +44 (0)20 7495 2379
Investor Relations Paul Spencer +44 (0)20 7495 2379
Optiva Securities Limited (Broker) Robert Emmet +44 (0)20 3981 4173

Frequently Asked Questions

What is OK-101 used for?

OK-101 is being developed to treat dry eye disease (DED).

When will the first patients visit for OK-101 trials?

The first-patient-first visit is anticipated in Q1 2023.

What type of trial is OK-101 in?

OK-101 is in a Phase 2, double-blind, placebo-controlled trial.

How does OK-101 work against dry eye disease?

OK-101 acts as an anti-inflammatory and pain reducer in ocular environments.

Where has OK-101 recently cleared customs?

OK-101 has cleared customs in the United States for trials.

Last updated: Feb 28, 2023