FDA clears compassionate urcosimod use as OKYO (OKYO) plans Phase 2b/3 NCP trial
Rhea-AI Filing Summary
OKYO Pharma Limited reports that the U.S. Food and Drug Administration has authorized a single-patient expanded access (compassionate use) IND for its drug candidate urcosimod (0.05%) to treat a patient with severe neuropathic corneal pain who has limited options and no FDA-approved treatments available. The IND was submitted by Pedram Hamrah, MD, at the University of South Florida, and urcosimod is being provided by OKYO under this authorization.
The company notes that urcosimod previously received the first IND to treat neuropathic corneal pain and was granted FDA fast track designation. OKYO recently reported positive pain-reduction data in an 18-patient Phase 2 trial in neuropathic corneal pain and earlier statistically significant results in a 240-patient Phase 2 trial in dry eye disease. It plans to start a 120-patient Phase 2b/3 multiple-dose study of urcosimod for neuropathic corneal pain this year.
Positive
- None.
Negative
- None.
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
January 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 January 23, 2026, OKYO Pharma LTD (the “Company”) issued this 6K announcing that the U.S. Food and Drug Administration (FDA) has authorized a single-patient expanded access (compassionate use) Investigational New Drug (IND) application submitted by Pedram Hamrah, MD, at the University of South Florida, for the use of urcosimod (0.05%) in a patient with neuropathic corneal pain.
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, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
| 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: January 23, 2026 | By: | /s/ Keeren Shah |
| Name: | Keeren Shah | |
| Title: | Chief Financial Officer | |
| 3 |
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | News Announcement, dated January 23, 2026 |
| 4 |
Exhibit 99.1
FDA Approves Compassionate Use of Urcosimod (0.05%) for the Treatment of Neuropathic Corneal Pain
London and New York, NY, January 23, 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 the U.S. Food and Drug Administration (FDA) has authorized a single-patient expanded access (compassionate use) Investigational New Drug (IND) application submitted by Pedram Hamrah, MD, at the University of South Florida, for the use of urcosimod (0.05%) in a patient with neuropathic corneal pain.
Under the FDA-authorized expanded access (IND 176297), urcosimod is being provided by OKYO Pharma for use in a patient with severe neuropathic corneal pain who has limited therapeutic options and no FDA-approved treatments available.
“We are grateful that this FDA authorization allows us to explore the potential of urcosimod in a patient with severe neuropathic corneal pain through a physician-sponsored expanded access IND,” said Pedram Hamrah, MD, Vice Chair of Academic Medicine, Department of Ophthalmology, University of South Florida. “Neuropathic corneal pain is a complex condition involving both immune-mediated inflammation and dysfunctional nerve signaling. Urcosimod’s proposed dual mechanism of action, potentially targeting both pathways provides a strong scientific rationale for investigation in this setting.”
“Supporting physician-sponsored expanded access to urcosimod under compassionate use in the U.S. highlights the pressing global need for innovative therapies to specifically address neuropathic corneal pain,” said Robert J. Dempsey, Chief Executive Officer, OKYO Pharma. “This also reflects the potential new hope for patients battling this debilitating painful condition with no FDA approved treatment available today.”
As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP this year.
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 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP 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 the FDA authorize for OKYO (OKYO) in this 6-K?
The FDA authorized a single-patient expanded access (compassionate use) IND for urcosimod (0.05%) in a patient with severe neuropathic corneal pain. The IND was submitted by Pedram Hamrah, MD, at the University of South Florida, and urcosimod is being supplied by OKYO Pharma.
What is urcosimod and what conditions is OKYO (OKYO) targeting?
Urcosimod (formerly OK-101) is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor found on immune cells of the eye and on certain neurons and glial cells. OKYO is developing it as an investigational therapy for neuropathic corneal pain (NCP) and for inflammatory eye diseases, including dry eye disease.
What prior clinical results has OKYO (OKYO) reported for urcosimod?
OKYO reports that urcosimod produced anti-inflammatory and pain-reducing activity in preclinical models and showed positive pain-reduction data in an 18-patient randomized, placebo-controlled, double-masked Phase 2 trial in neuropathic corneal pain. It also showed clear statistical significance in multiple endpoints in an earlier 240-patient Phase 2 trial in dry eye disease.
What are OKYO Pharma’s next clinical plans for urcosimod in NCP?
OKYO states that it plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat neuropathic corneal pain this year, building on its previously completed Phase 2 trial in NCP.
What is neuropathic corneal pain (NCP) and why is it important for OKYO (OKYO)?
Neuropathic corneal pain is described as a chronic, often debilitating condition marked by severe eye pain and sensitivity, sometimes affecting the face or head. It is thought to involve corneal nerve damage or dysfunction and inflammation. The company notes that there are no FDA-approved therapies specifically for NCP, so patients are often treated off-label with limited success, highlighting the potential need addressed by urcosimod.
What regulatory designations has urcosimod received from the FDA?
OKYO states that urcosimod was granted the first IND to treat patients with neuropathic corneal pain and has been awarded fast track designation by the FDA. The newly reported authorization adds a single-patient expanded access (compassionate use) IND for a severe NCP case.
