Urcosimod (OK-101) - (NEPTUNE)

July 8, 2026: OKYO Pharma Limited (Nasdaq: OKYO) reported positive FDA feedback from a Type D meeting supporting its regulatory and clinical path for urcosimod in neuropathic corneal pain (NCP). The FDA aligned on a single-dose Phase 3 study design and the company’s plan to position the upcoming NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation) trial as a pivotal study that could potentially support a single-trial registration strategy, contingent on successful results and continued FDA review.

OKYO said NEPTUNE will be a global Phase 3 trial in the U.S. and Europe, enrolling ~111 subjects randomized 2:1 to 0.05% urcosimod versus placebo. The company plans to seek FDA Breakthrough Therapy Designation to potentially accelerate development and review. Urcosimod already has an open IND for NCP and has received FDA Fast Track designation.

OKYO expects to initiate the global Phase 3 pivotal trial in the second half of this year.