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OKYO Pharma (OKYO) highlights urcosimod Phase 2 NCP results and plans 150-patient Phase 2b/3 trial

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(Neutral)
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(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

OKYO Pharma Limited filed a Form 6-K to share that an abstract on its lead drug candidate urcosimod (formerly OK-101) has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The paper will present proof-of-concept Phase 2 efficacy and safety results in neuropathic corneal pain during the Ocular Surface Disease II session on April 11, 2026, in Washington, DC.

The company highlights positive efficacy signals from the completed Phase 2 trial, including meaningful pain reduction and encouraging corneal nerve health trends, and describes urcosimod as a potential first-in-class therapy for neuropathic corneal pain, which currently has no FDA-approved treatments. OKYO reiterates prior FDA fast track designation and the first IND for NCP, and states it plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod in the first half of 2026.

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Insights

Conference acceptance showcases Phase 2 NCP data and flags an upcoming 150-patient Phase 2b/3 trial.

OKYO Pharma is advancing urcosimod, a ChemR23 agonist, for neuropathic corneal pain (NCP) and inflammatory eye disease. The abstract acceptance at the 2026 ASCRS Annual Meeting signals that proof-of-concept Phase 2 efficacy and safety data will be shared with a specialized ophthalmology audience.

The company cites meaningful pain reduction and encouraging corneal nerve health trends in its completed randomized, double-masked Phase 2 NCP study, as well as earlier positive results in a 240-patient Phase 2 dry eye trial. Urcosimod also benefits from FDA fast track designation and the first IND in NCP, which may streamline development steps.

OKYO plans a 150-patient Phase 2b/3 multiple-dose study of urcosimod for NCP in the first half of 2026. Future investor focus is likely to center on this trial’s design details, enrollment progress, and eventual readouts, as those will be key to assessing whether the encouraging early signals translate into registrational-quality evidence.

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

January 2026

 

 

 

Commission File Number: 001-41386

 

 

 

OKYO Pharma LTD

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

9th Floor

107 Cheapside

London

EC2V 6DN

(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): ☐

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

On January 30, 2026, OKYO Pharma LTD (the “Company”) issued this 6K announcing that an abstract on its lead candidate, urcosimod (formerly OK-101), has been accepted for presentation at the prestigious 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

 

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.

 

2

 

 

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: January 30, 2026 By: /s/ Keeren Shah
  Name:  Keeren Shah
  Title: Chief Financial Officer

 

3

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   News Announcement, dated January 30, 2026

 

4

 

 

Exhibit 99.1

 

 

OKYO Pharma Announces Acceptance of Urcosimod Phase 2 Study Results for Presentation at Prestigious ASCRS Annual Meeting

 

London and New York, NY, January 30, 2026. OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that an abstract on its lead candidate, urcosimod (formerly OK-101), has been accepted for presentation at the prestigious 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

 

The accepted paper, titled “Evaluation of Urcosimod in Neuropathic Corneal Pain: Efficacy and Safety Results from a Proof-of-Concept Pilot Phase 2 Study”, will be presented in the Ocular Surface Disease II session on Saturday, April 11, 2026, from 3:30 PM to 5:00 PM at the meeting in Washington, DC.

 

This acceptance follows a rigorous and highly competitive review process by the ASCRS Annual Meeting Program Committee, where only a limited number of submissions are selected each year. The abstract highlights efficacy and safety data from OKYO’s recently completed proof-of-concept Phase 2 study of urcosimod in patients with neuropathic corneal pain.

 

Robert Dempsey, Chief Executive Officer of OKYO Pharma, commented: “We are delighted to have our proof-of-concept Phase 2 data on urcosimod accepted for presentation at the prestigious 2026 ASCRS Annual Meeting. This recognition underscores the potential of urcosimod as a novel, first-in-class therapeutic for neuropathic corneal pain, a debilitating condition affecting patients with significant unmet need. Building on positive efficacy signals, including meaningful pain reduction and encouraging corneal nerve health trends from our study, this platform provides an important opportunity to share these results with leading ophthalmologists and advance our ongoing development efforts toward a planned larger Phase 2b/3 trial in the first half of 2026.”

 

The ASCRS Annual Meeting is a premier gathering for anterior segment surgeons and ophthalmologists focused on cataract, refractive, cornea, and glaucoma innovations.

 

As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

 

 

 

 

About Neuropathic Corneal Pain (NCP)

 

Neuropathic corneal pain (NCP) is a chronic, often debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of corneal sensory nerves, often in combination with inflammatory processes, and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP, resulting in patients being treated with limited or no success using various topical and systemic medications in an off-label manner.

 

About Urcosimod (formerly called OK-101)

 

Urcosimod 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, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2 trial involving 18 neuropathic corneal pain patients. Urcosimod showed clear statistical significance in multiple endpoints in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.

 

About OKYO Pharma

 

OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

 

For further information, please visit www.okyopharma.com.

 

For further inquiries:

 

OKYO Pharma Ltd

Paul Spencer, Business Development, and Investor Relations

+44 (0) 207 495 2379

Email: info@okyopharma.com

 

 

 

FAQ

What did OKYO Pharma (OKYO) announce in its latest 6-K filing?

OKYO Pharma announced that an abstract on its lead candidate, urcosimod, has been accepted for presentation at the 2026 ASCRS Annual Meeting. The presentation will cover proof-of-concept Phase 2 efficacy and safety results in neuropathic corneal pain, highlighting meaningful pain reduction and corneal nerve health trends.

What is urcosimod and what conditions is OKYO Pharma (OKYO) targeting?

Urcosimod is a lipid-conjugated chemerin peptide agonist of the ChemR23 receptor, developed for neuropathic corneal pain and inflammatory eye diseases. It has shown anti-inflammatory and pain-reducing activity in preclinical models and positive signals in Phase 2 trials for neuropathic corneal pain and dry eye disease.

What Phase 2 results will OKYO Pharma (OKYO) present at the ASCRS meeting?

OKYO will present Phase 2 proof-of-concept results for urcosimod in neuropathic corneal pain, including efficacy and safety data. The company reports meaningful pain reduction and encouraging corneal nerve health trends, which support ongoing development and plans for a larger Phase 2b/3 multiple-dose clinical trial.

When and where will OKYO Pharma’s urcosimod data be presented?

The urcosimod abstract will be presented at the 2026 ASCRS Annual Meeting in Washington, DC. It is scheduled in the Ocular Surface Disease II session on Saturday, April 11, 2026, from 3:30 to 5:00, reaching a focused audience of anterior segment specialists.

What are OKYO Pharma’s (OKYO) next clinical plans for urcosimod in neuropathic corneal pain?

OKYO plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod for neuropathic corneal pain in the first half of 2026. This larger study aims to build on proof-of-concept findings and could provide more robust evidence to support potential future regulatory discussions.

Does urcosimod have any regulatory designations for neuropathic corneal pain?

Yes. Urcosimod has received the first IND to treat neuropathic corneal pain and was awarded fast track designation by the U.S. Food and Drug Administration. These designations recognize the unmet need in NCP and may facilitate more efficient interaction with regulators during development.

Why is neuropathic corneal pain (NCP) an important focus for OKYO Pharma (OKYO)?

Neuropathic corneal pain is a chronic, often debilitating eye condition with severe pain and sensitivity. There are currently no FDA-approved therapies specifically for NCP, so patients often rely on off-label treatments with limited success, creating a significant unmet medical need that urcosimod aims to address.
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