LONDON and NEW YORK, July 08, 2026. OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for neuropathic corneal pain (NCP) and anterior segment eye diseases, today reported positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting. The feedback validates the Company’s regulatory and clinical path forward for urcosimod and supports advancement into a global Phase 3 pivotal trial for NCP.
The FDA aligned with OKYO on a single-dose Phase 3 study design and a potential single-trial registration pathway. This alignment strengthens the clinical development program for urcosimod and reduces regulatory uncertainty as the Company moves toward its pivotal study.
NEPTUNE Trial Design
OKYO unveiled NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), a global trial spanning the United States and Europe. The Company finalized the study design to enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo. OKYO plans to initiate the trial in the second half of this year.
Based on discussions with the Agency, OKYO is positioning NEPTUNE as a pivotal study that could support a single-trial registration strategy, subject to successful study results and continued FDA review.
Regulatory Strategy And Breakthrough Therapy Designation
The FDA feedback provides clarity around the Company’s updated regulatory strategy and supports a potentially streamlined clinical development pathway. To address the significant unmet medical need, OKYO plans to seek FDA Breakthrough Therapy Designation (BTD), which may further accelerate the development and review pathway.
Urcosimod is the first investigational therapy with an open IND specifically for the treatment of neuropathic corneal pain. It has received Fast Track designation from the FDA, reflecting the significant unmet need in a debilitating disease with no approved therapies.
Management Commentary
“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.”
“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.”
About Neuropathic Corneal Pain (NCP)
Neuropathic corneal pain is a chronic, often severe condition marked by 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 combined with inflammatory processes. NCP may occur alongside a variety of underlying ocular conditions and can produce pain disproportionate to observable clinical findings. The condition remains significantly under-researched. With no FDA-approved therapies, patients are treated with various topical and systemic medications off-label, often with limited or no success.
About Urcosimod
Urcosimod, OKYO’s lead candidate, is a first-in-class, lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein-coupled receptor. This receptor 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 activity through its dual mechanism of action, supporting its therapeutic potential for patients with neuropathic corneal pain.
About OKYO Pharma
OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing therapies for neuropathic corneal pain and anterior segment eye diseases, with ordinary shares listed 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, visit www.okyopharma.com.