OKYO Pharma outlines path to phase 3 NEPTUNE trial of urcosimod for neuropathic corneal pain

OKYO Pharma Limited has filed its annual report on Form 20-F for the fiscal year ended March 31, 2026, with the US Securities and Exchange Commission (SEC), and used the occasion to provide an update on its clinical progress toward a phase 3 pivotal trial of its lead candidate, urcosimod, in neuropathic corneal pain (NCP).¹

Keeren Shah, chief financial officer of OKYO Pharma, commented on the filing in a press release from the company, noting that a February 2026 public offering and other financing activity during the fiscal year raised approximately $25 million, leaving the company with roughly $20.6 million in cash as of the end of March 2026. “This has strengthened our cash position and provides us with ample financial resources to complete the NEPTUNE Phase 3 pivotal trial for urcosimod,” Shah said. “This advances us toward potential registration, creating long-term value for patients and shareholders.”

The NEPTUNE trial

OKYO is preparing to initiate NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), a global phase 3 pivotal study planned to begin enrollment in the second half of 2026. The trial is designed to enroll approximately 111 patients across sites in the US and Europe, randomized 2:1 to receive a single dose of 0.05% urcosimod or placebo.

The company stated the trial design follows positive feedback from a Type D meeting with the FDA and that NEPTUNE is intended as a potential registrational study that could support an efficient single-trial approval pathway should results prove favorable. A single-dose regimen would mark a notable simplification of the treatment course tested in earlier studies, if it holds up in a larger, controlled population.

How the program got here

NEPTUNE is the latest step in a clinical development path Ophthalmology Times has followed since urcosimod's proof-of-concept data first read out. In July 2025, OKYO reported positive top-line results from a phase 2 trial conducted at Tufts Medical Center in Boston, with Pedram Hamrah, MD, a leading expert in NCP, serving as principal investigator.² The randomized, double-masked, placebo-controlled trial was originally designed to enroll 48 patients but was closed early, with 17 patients completing the study, after the company said it had a “strong desire to unmask the clinical data for an early read-out on a drug effect.”

In the per-protocol population, patients treated with 0.05% urcosimod for 12 weeks reported a mean pain score improvement of 5.5 points, compared with 2.75 points in the placebo group, as measured on a 0-to-10 Visual Analogue Scale (VAS). Seventy-five percent of urcosimod-treated patients in that group achieved greater than 80% improvement in pain severity, with a marked reduction evident as early as week 4. In the intent-to-treat population, 67% of patients on 0.05% urcosimod achieved greater than 50% improvement in pain, compared with 33% on placebo.

Hamrah said at the time that the results were “very exciting and extremely encouraging,” adding that he found it “particularly encouraging that the drug showed a dramatic reduction in VAS pain scores in patients who have particularly high VAS pain scores, indicating a more severe form of the disease.”

Following the phase 2 readout, OKYO said it would pursue a multiple-ascending-dose (MAD) trial intended to enroll 100 NCP patients across several US sites in a randomized, placebo-controlled, double-masked design, with the goal of identifying an optimal registration dose and further characterizing urcosimod's micellar drug properties ahead of phase 3.³ That work, along with FDA fast track designation granted to urcosimod for NCP in May 2025, laid the groundwork for the Type D meeting that shaped NEPTUNE's single-trial registrational design.⁴

About urcosimod

Urcosimod is described by the company as a first-in-class, lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein-coupled receptor, 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. The company states urcosimod has demonstrated both ocular analgesic and anti-inflammatory pharmacologic activity through this dual mechanism, addressing an unmet need in a condition for which no FDA-approved treatment currently exists.

About OKYO Pharma

OKYO Pharma Limited is a clinical-stage biopharmaceutical company developing therapies for NCP and anterior segment eye diseases, with ordinary shares listed on the Nasdaq Capital Market. The company's Annual Report on Form 20-F is available on the SEC's website and on OKYO's investor relations page.

References

1. OKYO Pharma Limited. OKYO Pharma files annual report on Form 20-F and provides corporate update. News release. OKYO Pharma. July 20, 2026.

2. Harp MD. OKYO Pharma announces positive results from phase 2 trial of urcosimod for neuropathic corneal pain. Ophthalmology Times. July 18, 2025. Accessed July 21, 2026. https://www.ophthalmologytimes.com/view/okyo-pharma-announces-positive-results-from-phase-2-trial-of-urcosimod-for-neuropathic-corneal-pain

3. Harp MD. OKYO Pharma details next clinical stage of urcosimod development. Ophthalmology Times. September 22, 2025. Accessed July 21, 2026. https://www.ophthalmologytimes.com/view/okyo-pharma-details-next-clinical-stage-of-urcosimod-development

4. Harp M. FDA grants fast track designation to OKYO Pharma's urcosimod for treatment of neuropathic corneal pain. Ophthalmology Times. May 1, 2025. Accessed July 21, 2026. https://www.ophthalmologytimes.com/view/fda-grants-fast-track-designation-to-okyo-pharma-s-urcosimod-for-treatment-of-neuropathic-corneal-pain