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

NEPTUNE is designed as a registrational study, with ocular pain change as its primary efficacy endpoint.

Rhea-AI Summary

OKYO Pharma (OKYO) enrolled the first patients in its Phase 3 NEPTUNE trial evaluating urcosimod for neuropathic corneal pain.

Dr. Melissa Toyos enrolled the first patients at Toyos Clinic in Nashville, Tennessee. The study has initiated in the United States, with enrollment planned at multiple 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 in ocular pain from baseline to the end of treatment, measured using a visual analogue scale (VAS). Additional endpoints include quality-of-life scores and findings from in-vivo confocal microscopy, an eye-imaging technique. NEPTUNE is designed as a registrational study in accordance with FDA guidance. Neuropathic corneal pain currently has no FDA-approved treatment options.

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Positive

• Moderate pointFirst patients enrolled in Phase 3 NEPTUNE, advancing urcosimod’s clinical development for neuropathic corneal pain.
• Minor point. Forward-looking: it has not happened yet and may not happen.Multisite enrollment planned across the United States and Europe, including Italy, Spain and France.

Negative

• None.

Key Figures

Trial phase: Phase 3 Enrollment milestone: First patients enrolled Dosing regimen: 4 drops per day +1 more

Trial phase

Phase 3

Pivotal NEPTUNE trial of urcosimod

Enrollment milestone

First patients enrolled

NEPTUNE trial

Dosing regimen

4 drops per day

NEPTUNE study

Treatment duration

12 weeks

NEPTUNE study

Previous Clinical trial Reports

4 past events · Latest: Jul 08

Same Type 4 events

1. Jul 08

   FDA design feedback

   24h Move

   -5.1%

   FDA aligned on single-dose design and a potential single-trial registration pathway for urcosimod.

2. Jul 20

   Phase 3 planning

   24h Move

   -4.2%

   Reported cash intended to fund NEPTUNE and described its planned enrollment and single-dose design.

3. Mar 18

   Phase 2 data

   24h Move

   +1.3%

   Exploratory patient-reported quality-of-life improvements were reported for urcosimod versus placebo.

4. Dec 11

   Phase 2 data

   24h Move

   +6.9%

   Exploratory corneal nerve imaging showed median increases for urcosimod-treated patients.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

vas score, in-vivo confocal microscopy, g-protein-coupled-receptor, agonist

4 terms

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.

g-protein-coupled-receptor technical

"agonist of the ChemR23 G-protein-coupled-receptor"

A G-protein-coupled receptor is a protein on the surface of a cell that acts like an antenna or doorbell, sensing molecules outside the cell and triggering internal responses. These receptors are the target for many medicines because turning them on or off can change how a cell behaves, so they matter to investors as common drug targets where successful therapies can create substantial revenue and affect a company’s clinical and commercial prospects.

agonist medical

"lipid-conjugated chemerin peptide agonist"

An agonist is a drug or molecule that binds to a specific cell receptor and activates it, producing a biological effect—like a key that not only fits a lock but also turns it to open a door. For investors, knowing whether a therapy is an agonist helps predict how it might work in the body, its potential benefits and side effects, and how it could affect a company’s clinical success, regulatory outlook, and market value.

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• 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, Oct. 06, 2026 (GLOBE NEWSWIRE) -- 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

FAQ

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Has OKYO Pharma started enrolling patients in the Phase 3 NEPTUNE trial?

The first patients have been enrolled in NEPTUNE, the Phase 3 trial evaluating urcosimod for neuropathic corneal pain. Dr. Melissa Toyos enrolled them at Toyos Clinic in Nashville, Tennessee.

What is the primary endpoint in OKYO Pharma’s NEPTUNE trial?

The primary efficacy endpoint is change in ocular pain from baseline to the end of treatment, assessed using a visual analogue scale (VAS). Additional efficacy endpoints include quality-of-life scores and in-vivo confocal microscopy findings.