OKYO Pharma (NASDAQ: OKYO) gets FDA feedback on pivotal Phase 3 NCP trial
Rhea-AI Filing Summary
OKYO Pharma reports positive feedback from a U.S. FDA Type D meeting on its lead drug candidate, urcosimod, for neuropathic corneal pain (NCP). The agency aligned with a single-dose global Phase 3 pivotal trial, called NEPTUNE, and acknowledged a potential single-trial registration pathway, subject to successful results and continued review.
The NEPTUNE study is planned in the United States and Europe, enrolling about 111 patients in a 2:1 randomization of 0.05% urcosimod versus placebo. Urcosimod already has Fast Track designation, and OKYO plans to seek Breakthrough Therapy Designation to further accelerate development in this debilitating disease with no FDA-approved treatments.
Positive
- Regulatory alignment on pivotal Phase 3 trial: FDA Type D feedback supports a single-dose global Phase 3 design for urcosimod in neuropathic corneal pain and a potential single-trial registration pathway, clarifying and potentially streamlining approval plans in a disease with no existing FDA-approved treatments.
Negative
- None.
Insights
FDA feedback supports a streamlined Phase 3 path for OKYO’s NCP drug.
The FDA Type D meeting gave OKYO Pharma alignment on a single-dose Phase 3 design for urcosimod in neuropathic corneal pain. Positioning the NEPTUNE trial as a pivotal study with a potential single-trial registration pathway simplifies the regulatory roadmap compared with multi-trial programs.
Urcosimod already holds Fast Track designation, and OKYO plans to seek Breakthrough Therapy Designation, which can further expedite review. The planned 111-patient, 2:1 randomized global trial in the United States and Europe provides a clear next step; actual impact will depend on Phase 3 outcomes disclosed in future updates.
Key Figures
Key Terms
Type D meeting regulatory
Fast Track designation regulatory
Breakthrough Therapy Designation regulatory
pivotal trial financial
neuropathic corneal pain medical
ChemR23 G-protein-coupled-receptor medical
FAQ
What did OKYO Pharma (OKYO) announce regarding its FDA Type D meeting?
What is the NEPTUNE Phase 3 trial that OKYO Pharma plans to run?
What regulatory designations does urcosimod have for neuropathic corneal pain?
Why is neuropathic corneal pain (NCP) important to OKYO Pharma’s strategy?
What is urcosimod and how does it work in neuropathic corneal pain?
When does OKYO Pharma plan to start the NEPTUNE Phase 3 trial for NCP?
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
July 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 July 8, 2026, OKYO Pharma LTD (the “Company”) issued this 6K announcing positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting, validating the Company’s regulatory and clinical path forward for urcosimod and supporting advancement into a global Phase 3 pivotal trial for 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)
| 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: July 8, 2026 | By: | /s/ Keeren Shah |
| Name: | Keeren Shah | |
| Title: | Chief Financial Officer | |
| 3 |
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | News Announcement, dated July 8, 2026 |
| 4 |
Exhibit 99.1
OKYO Pharma Reports Positive Feedback from FDA Type D Meeting and Accelerates Urcosimod into Global Phase 3 Pivotal Trial for Neuropathic Corneal Pain
| ● | FDA alignment on a single-dose Phase 3 study design and potential single-trial registration pathway further strengthens the Company’s clinical development program for urcosimod |
| ● | Company unveils NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), a global trial in the United States and Europe |
| ● | Study design finalized to enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo |
| ● | To address the significant unmet medical need, the company plans to seek FDA Breakthrough Therapy Designation (BTD), which may further accelerate the development and review pathway |
London and New York, NY, July 8, 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 positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting, validating the Company’s regulatory and clinical path forward for urcosimod and supporting advancement into a global Phase 3 pivotal trial for NCP.
“The outcome of our Type D meeting represents an important milestone and de-risking of our development program,” said Flavio Mantelli, MD, PhD, Chief Medical Officer of OKYO Pharma. “The FDA’s feedback provided regulatory validation of our upcoming NEPTUNE clinical trial design, accelerating both the clinical development plan for urcosimod and our ability to generate meaningful data for patients, physicians, and regulators.”
The FDA feedback provides increased clarity around the Company’s updated regulatory strategy, reducing uncertainty and further supporting OKYO’s plan to advance urcosimod through a potentially streamlined clinical development pathway. Based on discussions with the Agency, OKYO is positioning the planned NEPTUNE trial as a pivotal study that could support a potential single-trial registration strategy, subject to successful study results and continued FDA review.
“Our strong balance sheet, together with regulatory clarity from the FDA supporting our accelerated clinical development plan, positions us to advance directly into our global Phase 3 urcosimod trial,” said Robert J. Dempsey, Chief Executive Officer of OKYO Pharma. “Most importantly, we remain committed to bringing a potential first in class, non-opioid treatment to patients living with this debilitating condition, for which there are currently no FDA-approved therapies.”
Urcosimod is the first investigational therapy with an open IND specifically for the treatment of neuropathic corneal pain and has received Fast Track designation by the U.S. Food and Drug Administration (FDA), reflecting the significant unmet need in this debilitating disease for which there are currently no approved therapies.
About Neuropathic Corneal Pain (NCP)
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 is significantly under-researched, with no FDA-approved therapies, resulting in patients being treated with various topical and systemic medications in an off-label manner, often with limited or no success.
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. OKYO plans to initiate a global Phase 3 pivotal clinical trial in the second half of this year, enrolling approximately 111 patients to evaluate a single-dose regimen of urcosimod for the treatment of NCP.
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