OKYO Pharma's Urcosimod Gains Key Validation for Eye Pain Therapy

LONDON and NEW YORK – January 30, 2026 – In a significant development for patients suffering from chronic and severe eye pain, OKYO Pharma has announced that results from its Phase 2 study of urcosimod will be presented at the prestigious 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The acceptance provides crucial validation for the investigational drug, positioning it as a potential first-in-class treatment for neuropathic corneal pain (NCP), a debilitating condition with no currently approved therapies.

The presentation, titled "Evaluation of Urcosimod in Neuropathic Corneal Pain: Efficacy and Safety Results from a Proof-of-Concept Pilot Phase 2 Study," is scheduled for April 11, 2026, in Washington, DC. This showcase at a premier ophthalmology conference follows a highly competitive review process, underscoring the scientific community's interest in the drug's promising data.

A Beacon of Hope for a Debilitating Condition

Neuropathic corneal pain is a chronic and often incapacitating condition that goes far beyond the discomfort of simple dry eye. Patients experience severe, persistent symptoms such as burning, stinging, and sharp, electric-shock-like pain in the eyes, which can sometimes radiate to the face and head. The condition is believed to arise from damage or dysfunction of the sensory nerves in the cornea, often coupled with underlying inflammation.

The impact on quality of life is profound, yet the therapeutic landscape is barren. There are currently no treatments specifically approved by the Food and Drug Administration (FDA) for NCP. This forces physicians to rely on a patchwork of off-label medications—including topical corticosteroids, immunomodulators, and systemic neuropathic pain agents—which provide limited or no relief for many. This treatment gap affects a substantial patient population, with an estimated 3.075 million cases of neuropathic ocular pain across seven major global markets in 2023, a number projected to grow.

Diagnosis itself presents a significant hurdle. Patients often suffer for years, cycling through failed dry eye treatments because the tell-tale signs of nerve damage are not always visible during a standard eye exam. This "pain without stain" phenomenon can lead to misdiagnosis and delayed care, leaving patients in a state of chronic suffering.

Scientific Innovation Targeting Pain and Inflammation

Urcosimod represents a novel approach to treating this complex condition. The drug is a lipid-conjugated chemerin peptide agonist, a sophisticated molecule designed to target a specific receptor known as ChemR23. This receptor is found on both immune cells that drive inflammation and on nerve cells involved in pain signaling. By activating this receptor, urcosimod is believed to exert a dual effect: calming the inflammatory response in the eye and directly modulating the pain pathways.

This mechanism is a significant departure from existing off-label treatments. The drug was developed using a proprietary membrane-anchored-peptide technology, which adds a lipid anchor to the molecule. This design is intended to increase the drug's residence time on the surface of the eye, potentially allowing for a longer-lasting therapeutic effect.

The data accepted for the ASCRS presentation comes from a recently completed Phase 2 proof-of-concept study. While the trial was small, involving 18 patients with long-term, treatment-resistant NCP, the results were highly encouraging. The study demonstrated meaningful pain reduction and positive trends in corneal nerve health. In fact, an analysis of the per-protocol participants showed that 75% achieved a remarkable pain reduction of over 80% on a standard pain scale after 12 weeks of treatment.

This builds on previous success in a much larger 240-patient Phase 2 trial, where urcosimod showed statistically significant efficacy in treating dry eye disease, a related inflammatory condition. Together, these trials suggest a broad potential for the drug in tackling ocular surface diseases.

Navigating the Path to Market

For a clinical-stage company like OKYO Pharma, which currently generates no revenue and relies on investor funding, external validation is critical. The acceptance of its data at the ASCRS meeting provides just that. Being selected to present at such an influential forum, attended by thousands of leading ophthalmologists and industry experts, lends significant credibility to urcosimod and the company's clinical program.

"We are delighted to have our proof-of-concept Phase 2 data on urcosimod accepted for presentation at the prestigious 2026 ASCRS Annual Meeting," said Robert Dempsey, Chief Executive Officer of OKYO Pharma, in a statement. "This recognition underscores the potential of urcosimod as a novel, first-in-class therapeutic for neuropathic corneal pain, a debilitating condition affecting patients with significant unmet need."

The company's path forward is further bolstered by a Fast Track designation granted by the FDA. This status is reserved for drugs that treat serious conditions and fill an unmet medical need, and it is designed to expedite the development and review process. Key benefits include more frequent communication with the FDA and the ability to submit sections of a New Drug Application on a rolling basis, potentially shortening the time to market.

Adding to this momentum, OKYO Pharma recently held a successful Type C meeting with the FDA to discuss its plans for the next stage of clinical trials. The agency endorsed the proposed study design, endpoints, and manufacturing strategy, providing a clear and de-risked regulatory pathway for the pivotal program.

The Road Ahead: Pivotal Trials and Market Positioning

With promising data and regulatory support in hand, OKYO Pharma is preparing to launch a larger, pivotal Phase 2b/3 trial in the first half of 2026. The study is planned to enroll 150 patients and will be a multi-dose, randomized, placebo-controlled trial designed to provide the substantial evidence of effectiveness required for regulatory approval.

The FDA has confirmed that a reduction in pain, as measured by the Visual Analogue Scale (VAS), can serve as the primary endpoint. The agency also endorsed the use of the Ocular Pain Assessment Survey (OPAS) as a key secondary measure to capture the drug's impact on quality of life and daily function, recognizing that the burden of NCP extends far beyond a simple pain score.

The competitive landscape for NCP-specific treatments is notably sparse, placing urcosimod in a strong position to become a first-in-class therapy. While larger pharmaceutical companies like AbbVie and Bausch & Lomb are active in the broader ocular health space, few are in late-stage development for this specific indication. This creates a significant market opportunity for OKYO Pharma if its upcoming trial proves successful.

Building on the positive efficacy signals and the clear regulatory guidance, the upcoming trial represents a critical milestone for the company and a tangible source of hope for patients who have long awaited an effective solution for their chronic pain.