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OKYO Pharma (OKYO) showcases urcosimod Phase 2 data and plans 150-patient trial

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Form Type
6-K

Rhea-AI Filing Summary

OKYO Pharma is highlighting progress for its lead eye therapy, urcosimod, around the 2026 ASCRS meeting in Washington, DC. The company will convene a Scientific Advisory Board of leading ophthalmology experts to review Phase 2 clinical data and guide the next clinical program.

In parallel, principal investigator Dr. Pedram Hamrah will present Phase 2 proof-of-concept results on urcosimod in neuropathic corneal pain, covering efficacy and safety. Urcosimod holds an IND and FDA Fast Track designation for this indication, and OKYO plans a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026.

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Insights

OKYO is organizing expert input and visibility as urcosimod moves toward a larger Phase 2b/3 trial.

OKYO Pharma is using the high-profile ASCRS meeting to both present Phase 2 neuropathic corneal pain data and hold a Scientific Advisory Board session. This helps validate trial design and endpoints by drawing on leading corneal and ocular surface disease specialists.

Urcosimod already has an IND and FDA Fast Track designation for neuropathic corneal pain, and prior Phase 2 trials showed pain reduction and dry eye efficacy signals. The planned 150-patient Phase 2b/3 multiple-dose study in the first half of 2026 will be a key step in confirming these early results.

Phase 2 NCP trial size 18 patients Randomized, placebo-controlled, double-masked Phase 2 neuropathic corneal pain study
Dry eye Phase 2 trial size 240 patients Multi-center, double-masked, placebo-controlled Phase 2 dry eye disease trial
Planned Phase 2b/3 NCP trial size 150 patients Planned multiple-dose study of urcosimod in neuropathic corneal pain
ASCRS presentation date April 11, 2026 Ocular Surface Disease II session, 3:30–5:00 PM, Washington, DC
FDA status Fast Track and IND First IND specifically for neuropathic corneal pain plus Fast Track designation
Phase 2b/3 start timing First half of 2026 Planned initiation of 150-patient multiple-dose urcosimod study
Scientific Advisory Board financial
"it will hold a key Scientific Advisory Board (SAB) meeting with leading ophthalmology experts"
A scientific advisory board is a group of independent experts—often scientists, clinicians or technical specialists—who give a company guidance on its research, product development and regulatory strategy. For investors, their role is like an external quality check: credible experts can reduce technical risk, improve the chance of regulatory approval or successful products, and boost confidence that management’s science claims are realistic and well-directed.
neuropathic corneal pain medical
"developing investigational therapies for the treatment of neuropathic corneal pain (NCP)"
Neuropathic corneal pain is chronic, often severe eye pain caused by damage or malfunction in the tiny nerves of the cornea, where the eye surface can feel burning, stinging, or like something is in it despite little visible damage. It matters to investors because it represents a persistent, hard-to-treat medical need that drives demand for new drugs, diagnostics, devices and regulatory approvals, similar to how fixing a frayed electrical wire stops false alarm signals.
Fast Track designation regulatory
"has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA)"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
IND regulatory
"first investigational therapy to receive an IND specifically for the treatment of neuropathic corneal pain"
proof-of-concept clinical
"Efficacy and Safety Results from a Proof-of-Concept Pilot Phase 2 Study"
A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.

 

 

 

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

 

April 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 April 7, 2026, OKYO Pharma LTD (the “Company”) issued this 6K announcing that it will hold a key Scientific Advisory Board (SAB) meeting with leading ophthalmology experts during the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in Washington, DC. The SAB meeting, scheduled to take place alongside the conference, will bring together prominent corneal and ocular surface disease specialists to review clinical data for the company’s lead candidate, urcosimod and provide strategic guidance on the upcoming clinical program.

 

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, This report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Reg. No. 333-293145)

 

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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: April 7, 2026 By: /s/ Keeren Shah
  Name: Keeren Shah
  Title: Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   News Announcement, dated April 7, 2026

 

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Exhibit 99.1

 

A blue and black logo

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OKYO Pharma Announces Scientific Advisory Board Meeting and Urcosimod Data Presentation During ASCRS Annual Meeting

 

London and New York, NY, April 7, 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 announced that it will hold a key Scientific Advisory Board (SAB) meeting with leading ophthalmology experts during the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in Washington, DC. The SAB meeting, scheduled to take place alongside the conference, will bring together prominent corneal and ocular surface disease specialists to review clinical data for the company’s lead candidate, urcosimod and provide strategic guidance on the upcoming clinical program.

 

In conjunction with the SAB meeting, Dr. Pedram Hamrah, Professor of Ophthalmology, Vice Chair of academic medicine, and Director of clinical and translational research, University of South Florida and principle investigator of the urcosimod Phase 2 study, will present a paper at ASCRS, titled “Evaluation of Urcosimod in Neuropathic Corneal Pain: Efficacy and Safety Results from a Proof-of-Concept Pilot Phase 2 Study”. This paper 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 dual presence at ASCRS with both a formal data presentation and a dedicated Scientific Advisory Board meeting represents an important milestone for OKYO,” said Robert Dempsey, Chief Executive Officer of OKYO Pharma. “The SAB meeting will allow us to engage deeply with top key opinion leaders in the field to refine our clinical strategy as we prepare to initiate the next clinical trial of urcosimod in the first half of 2026. We are encouraged by the efficacy signals and safety profile observed in the Phase 2 study and look forward to leveraging the collective expertise of the SAB to accelerate the development of this therapy addressing a significant unmet need for patients suffering from neuropathic corneal pain.”

 

The ASCRS Annual Meeting is widely regarded as one of the most prestigious gatherings for anterior segment surgeons and ophthalmologists, making it an ideal setting for both the data presentation and high-level scientific discussion.

 

Urcosimod is the first investigational therapy to receive an IND specifically for the treatment of neuropathic corneal pain and has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

 

 

 

 

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 (OKYO) announce in this Form 6-K?

OKYO announced a Scientific Advisory Board meeting and a clinical data presentation for urcosimod during the 2026 ASCRS Annual Meeting. Experts will review Phase 2 neuropathic corneal pain data and advise on the upcoming clinical program, including a larger planned Phase 2b/3 study.

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

Urcosimod is a chemerin peptide agonist targeting the ChemR23 receptor on immune and neural cells. OKYO is developing it for neuropathic corneal pain and inflammatory eye diseases, supported by anti-inflammatory and pain-reducing activity in preclinical models and positive signals in clinical Phase 2 studies.

What clinical data on urcosimod will be presented at ASCRS 2026?

Principal investigator Dr. Pedram Hamrah will present Phase 2 proof-of-concept data titled “Evaluation of Urcosimod in Neuropathic Corneal Pain” in the Ocular Surface Disease II session on April 11, 2026, covering efficacy and safety results from a pilot trial in neuropathic corneal pain patients.

What future clinical trial is OKYO (OKYO) planning for urcosimod?

OKYO plans a 150-patient Phase 2b/3 multiple-dose study of urcosimod in neuropathic corneal pain in the first half of 2026. This larger trial aims to build on earlier Phase 2 pain-reduction data and further assess efficacy and safety in a more robust patient population.

What regulatory designations does urcosimod have for neuropathic corneal pain?

Urcosimod is the first investigational therapy to receive an IND specifically for neuropathic corneal pain and has FDA Fast Track designation. These designations reflect regulatory recognition of the unmet need and can facilitate development and review timelines for this novel ocular pain therapy.

What prior clinical results has OKYO (OKYO) reported for urcosimod?

OKYO reported positive neuropathic corneal pain reduction data in a randomized, placebo-controlled, double-masked Phase 2 trial with 18 patients. Urcosimod also showed clear statistical significance on multiple endpoints in an earlier 240-patient Phase 2 trial evaluating treatment of dry eye disease symptoms.

Filing Exhibits & Attachments

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