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OKYO Pharma starts Phase 3 urcosimod patient enrollment

NEPTUNE will assess ocular pain after 12 weeks of dosing, with quality-of-life scores and in-vivo confocal microscopy also included as efficacy measures.

(Moderate)

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Form Type
6-K

Rhea-AI Filing Summary

OKYO Pharma Ltd (OKYO) announced that the first patients have been enrolled in its Phase 3 NEPTUNE trial of investigational urcosimod for neuropathic corneal pain. Dr. Melissa Toyos enrolled the first patients at Toyos Clinic in Nashville. Participants will receive 4 drops per day for 12 weeks, and the trial is designed as a registrational study in accordance with FDA guidance.

The study is planned for clinical sites across the United States and Europe, including Italy, Spain and France. Its primary efficacy endpoint is change from baseline to the end of treatment in ocular pain assessed by VAS score; additional endpoints include quality-of-life scores and in-vivo confocal microscopy findings.

Filing Explained

OKYO states that this 6-K is incorporated by reference into its Form F-3 registration statement, while the attached announcement is furnished and is not deemed filed for Section 18 purposes.

Trial phase Phase 3 NEPTUNE study of urcosimod
Daily dose 4 drops per day NEPTUNE study dosing
Treatment period 12 weeks NEPTUNE study dosing period
neuropathic corneal pain medical
"trial of urcosimod for neuropathic corneal pain"
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.
VAS score medical
"ocular pain assessed by VAS score"
A VAS score is a patient-reported measure of symptom intensity obtained from a visual analogue scale: a straight line (commonly 10 cm or 100 mm long) with anchors at each end (for example, 'no pain' and 'worst imaginable pain'). The patient marks a point on the line that represents their current symptom level, and the distance from the 'no symptom' anchor is measured and reported as the score (often converted to 0–10 or 0–100). It quantifies subjective symptoms for comparison over time or between groups, but it is inherently subjective and can vary with how the scale is administered and interpreted.
in-vivo confocal microscopy medical
"in-vivo confocal microscopy (IVCM) findings"
A medical imaging technique that produces high-resolution, microscopic pictures of living tissue without removing it from the body. A confocal microscope focuses a narrow beam of light (usually a laser) into the tissue and collects light from a very thin focal plane through a small aperture, which yields optical “slices” with cellular-level detail; the microscope scans point-by-point or line-by-line to build an image. In-vivo confocal microscopy is used directly on patients (for example to examine the cornea, skin, or mucous membranes), gives real-time structural images at shallow depths, and is non‑destructive. Limitations include a small field of view, limited penetration depth compared with standard clinical imaging, dependence on operator technique, and the fact that it shows cellular structure and reflectivity rather than definitive molecular or histological staining results.
ChemR23 G-protein-coupled-receptor technical
"agonist of the ChemR23 G-protein-coupled-receptor"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Where will OKYO's NEPTUNE trial enroll patients?

NEPTUNE plans to enroll patients at multiple clinical sites across the United States and Europe, including Italy, Spain and France.

What additional outcomes will OKYO's NEPTUNE trial assess?

Additional efficacy endpoints include quality-of-life scores and in-vivo confocal microscopy (IVCM) findings.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

 

October 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 October 6, 2026, OKYO Pharma LTD (the “Company”) issued this 6K announcing first patients enrolled in Phase 3 NEPTUNE trial of urcosimod for neuropathic corneal pain (NCP).

 

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: October 6, 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 October 6, 2026

 

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Exhibit 99.1

 

 

OKYO Pharma Announces First Patients Enrolled in Phase 3 Pivotal Trial of Urcosimod for Neuropathic Corneal Pain

 

●NEPTUNE is evaluating urcosimod as a potential first-in-class treatment for neuropathic corneal pain
●First patients enrolled by Dr. Melissa Toyos at Toyos Clinic in Nashville, TN

 

London and New York, NY, October 6, 2026. OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and anterior segment eye diseases, today announced first patients enrolled in Phase 3 NEPTUNE trial of urcosimod for neuropathic corneal pain (NCP).

 

“Neuropathic corneal pain is one of the most debilitating conditions I see in my practice, and right now we have no FDA approved therapy to offer these patients, many of whom have tried everything and are still suffering,” said Melissa Toyos, MD. “I believe this trial represents an important step toward determining whether this investigational therapy can address the significant unmet need faced by patients with neuropathic corneal pain.”

 

Neuropathic corneal pain (NCP) is a chronic, often severe, 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 the corneal sensory nerves, often in combination with inflammatory processes, and may occur in association with a variety of underlying ocular conditions exhibiting pain that may be disproportionate to observable clinical findings. NCP remains a condition with no FDA-approved treatment options, representing a significant unmet medical need for patients.

 

“The activation of the first site and initiation of OKYO’s NEPTUNE trial represent an important milestone for building the clinical evidence necessary to support the potential first disease modifying treatment for neuropathic corneal pain (NCP),” said Flavio Mantelli, MD, PhD, Chief Medical Officer of OKYO Pharma. “We are honored to have Dr. Toyos enroll the first patients in the study while activation of other sites expands across leading U.S. medical centers.”

 

 
 

 

About NEPTUNE Phase 3 Study

 

The NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation) is evaluating urcosimod for neuropathic corneal pain (NCP) clinical trial has initiated in the United States. Patients will be enrolled at multiple clinical sites across the United States and Europe, including Italy, Spain, and France. Patients will receive 4 drops per day for 12 weeks. The primary efficacy endpoint is the change from baseline to end of treatment in ocular pain assessed by VAS score. Additional efficacy endpoints include Quality-of-Life scores and in-vivo confocal microscopy (IVCM) findings. The multicenter trial is designed as a registrational study in accordance with the U.S. Food and Drug Administration (FDA) guidance. For more information on the NEPTUNE study, please visit: NEPTUNE and NCT07838506 on clinicaltrials.gov.

 

About Urcosimod

 

OKYO’s lead candidate, urcosimod, is a first-in-class, 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 ocular inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has demonstrated ocular analgesic and anti-inflammatory pharmacologic activity through its dual mechanism of action, supporting its therapeutic potential to address the significant unmet medical need for patients with neuropathic corneal pain.

 

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 anterior segment eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. For more information, please visit www.okyopharma.com and follow us on LinkedIn.

 

For further inquiries:

 

OKYO Pharma Ltd

 

Paul Spencer

Business Development and Investor Relations

+44 (0) 207 495 2379

Email: info@okyopharma.com

 

 

Filing Exhibits & Attachments

2 documents

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