OKYO Pharma gets FDA Type D feedback, moves urcosimod into global Phase 3 for eye pain

OKYO Pharma Limited announced on July 8, 2026 that it received 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.¹

The company said the FDA discussion clarified its regulatory strategy, and based on those discussions, OKYO is positioning the planned NEPTUNE trial as a pivotal study that could potentially support a single-trial registration strategy, contingent on successful results and continued FDA review.¹

The newly named trial, NEPTUNE, is described as a global trial in the United States and Europe, with a study design finalized to enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo.¹ The company also said it plans to seek FDA Breakthrough Therapy Designation, which it said may further accelerate the development and review pathway.¹

Regarding regulatory history, the release states that urcosimod is the first investigational therapy with an open IND specifically for treating neuropathic corneal pain and has already received Fast Track designation from the FDA.¹

On the science, OKYO describes urcosimod as a lipid-conjugated chemerin peptide that acts as an agonist at the ChemR23 receptor, a target found on immune cells in the eye involved in inflammation as well as on neurons and glial cells in the dorsal root ganglion, according to the company. The company said urcosimod has demonstrated ocular analgesic and anti-inflammatory pharmacologic activity through its dual mechanism of action.¹

OKYO said it plans to initiate the global Phase 3 pivotal trial in the second half of this year, enrolling approximately 111 patients to evaluate a single-dose regimen of urcosimod for NCP treatment.¹ The filing was signed by Chief Financial Officer Keeren Shah on July 8, 2026.