6-K - OKYO - Equibles

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM6-K

REPORTOF FOREIGN PRIVATE ISSUER

PURSUANTTO RULE 13a-16 OR 15d-16

UNDERTHE SECURITIES EXCHANGE ACT OF 1934

June2023

CommissionFile Number: 001-41386

OKYOPharma LTD

(Exact Name of Registrant as Specified in Its Charter)

9^th^Floor

107Cheapside

London

EC2V6DN

(Address of registrant’s principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

INFORMATIONCONTAINED IN THIS REPORT ON FORM 6-K

On June 6, 2023, OKYO Pharma LTD (the “Company”) issued this 6K announcing that, Randomized Segment Now Underway in Phase 2 Clinical Trial of Topical Ocular OK-101 for Dry Eye Disease, a copy of which is furnished as Exhibit 99.1

The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	OKYO Pharma LTD
Date:<br> June 6, 2023	By:	/s/ Keeren Shah
	Name:	Keeren<br> Shah
	Title:	Chief<br> Financial Officer

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EXHIBITINDEX

Exhibit No.	Description
99.1	News Announcement, dated June 6, 2023

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Exhibit 99.1

OKYOPharma Announces Randomized Segment Now Underway in Phase 2 Clinical Trial of Topical Ocular OK-101 for Dry Eye Disease

●	Trial<br> designed with a two-week run-in period to reduce the well-known placebo effect in trials involving pain component
●	Top-line<br> data from trial anticipated in Q4, 2023

London and New York, NY, June 6, 2023 – 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 that patients are now being dosed in the randomized portion of the phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following the two-week placebo run-in period intended to minimize the placebo effect.

“A two-week placebo run-in period involving topical ocular dosing of placebo is an innovative approach used by our clinical development partner, Ora Inc. This design feature reduces the well-known placebo effect for ocular trials such as ours that include an ocular discomfort readout,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “This run-in period enables us to evaluate potential patients for the placebo effect during the run-in screening period, improving patient selection for the randomized treatment portion of the trial. Importantly, this first clinical study is also designed to include two pre-specified primary efficacy endpoints which are the hallmark of phase 3 registration trials, and one of the efficacy endpoints deals specifically with ocular discomfort.”

Dry eye disease is a common condition that occurs when one’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 ocular surface.

Aboutthe Phase 2 Trial Design

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 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 0.05% OK-101, and the third cohort receiving 0.1% 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 or https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).

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AboutOKYO

OKYO Pharma Limited (NASDAQ: OKYO) is a life sciences company admitted to listing on the NASDAQ capital market. 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.

AboutOK-101

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 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.

Forward-LookingStatements

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 website at www.okyopharma.com

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.

Enquiries:

OKYO Pharma Limited	Gary<br> S. Jacob, Chief Executive Officer	U.S. 917-497-7560
Investor Relations	Paul<br> Spencer	+44<br> (0)20 7495 2379

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