FDA Approves Compassionate Use of Urcosimod (0.05%) for the Treatment of Neuropathic Corneal Pain
MWN-AI** Summary
OKYO Pharma Limited (Nasdaq: OKYO) announced that the U.S. Food and Drug Administration (FDA) has granted a compassionate use authorization for its investigational therapy, urcosimod (0.05%), aimed at treating neuropathic corneal pain (NCP). This single-patient expanded access Investigational New Drug (IND) application was submitted by Dr. Pedram Hamrah at the University of South Florida for a patient suffering from severe NCP, a condition characterized by chronic eye pain and sensitivity due to nerve damage. Currently, there are no FDA-approved treatments specifically targeting NCP, leaving patients with limited options.
Urcosimod is designed to address both immune-mediated inflammation and dysfunctional nerve signaling—two key factors in NCP. Dr. Hamrah emphasized the significance of exploring urcosimod's dual action in this patient's context, underlining the unmet medical need for effective therapies in treating this debilitating condition. OKYO Pharma's CEO, Robert J. Dempsey, echoed this sentiment, commenting on the importance of compassionate use and the need for innovative treatments for those battling NCP without viable options.
Urcosimod has previously been awarded fast track designation by the FDA, and the company plans to initiate a Phase 2b/3 study this year, with 120 participants in multiple doses to further explore its efficacy in treating NCP. The drug has shown promise in earlier trials, demonstrating statistical significance in pain reduction among patients with various ophthalmic conditions.
As OKYO continues to pursue its clinical development, the compassionate use authorization marks a hopeful advancement for patients suffering from neuropathic corneal pain, highlighting the critical need for targeted therapies in this area.
MWN-AI** Analysis
The recent announcement regarding the FDA's approval of compassionate use for OKYO Pharma's urcosimod (0.05%) marks a significant milestone for the company and indicates substantial potential in the biopharmaceutical market, especially in the treatment of neuropathic corneal pain (NCP). As a clinical-stage biopharmaceutical firm developing therapies for eye diseases, OKYO is poised to benefit from this expanded access initiative, as it underscores both the urgent need for effective treatments in this niche market and the company's innovative approach.
Urcosimod's dual mechanism of action—targeting inflammation and nerve signaling dysfunction—presents a compelling rationale for its investigation, particularly given the current lack of FDA-approved therapeutic options for NCP. The momentum gained from the compassionate use IND can potentially enhance investor confidence leading into the planned 120-patient Phase 2b/3 multiple-dose study set to commence later this year. Investors should be closely monitoring the company's clinical trial outcomes and patient feedback, as successful results could lead to expedited market entry and provide OKYO a competitive edge in the ophthalmic pharmaceuticals landscape.
From a market perspective, the approval signals possible growth opportunities for OKYO's stock, potentially leading to a bullish trend. The biopharma sector often reacts positively to favorable regulatory news, and this could serve as a catalyst for short-term gains in share price, especially considering recent enthusiasm around innovative therapies.
However, while the potential for upside exists, prudent investors should also consider inherent risks associated with clinical-stage companies. Fluctuations in stock performance due to clinical trial outcomes, competitive responses, and market sentiment will impact OKYO’s valuation in the near to medium term. Diversification and a keen eye on upcoming trial results can enhance investment strategies in this promising yet volatile sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
LONDON and NEW YORK, Jan. 23, 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 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**
How does OKYO Pharma Limited OKYO's recent FDA authorization for urcosimod's compassionate use impact its clinical strategy in addressing neuropathic corneal pain (NCP) in major cities like London and New York?
Considering the innovative therapies being developed by OKYO Pharma Limited OKYO, what are the potential market implications for NCP treatments in urban healthcare systems like those in London and New York?
How might the physician-sponsored expanded access IND authorized by OKYO Pharma Limited OKYO influence patient care and treatment options for NCP in leading healthcare hubs such as London and New York?
What are the regulatory challenges that OKYO Pharma Limited OKYO might face as it seeks to expand its treatment offerings for neuropathic corneal pain in competitive markets like London and New York?
**MWN-AI FAQ is based on asking OpenAI questions about OKYO Pharma Limited (NASDAQ: OKYO).
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