OKYO Pharma Announces First Patients Enrolled in Phase 3 Pivotal Trial of Urcosimod for Neuropathic Corneal Pain

OKYO Pharma (OKYO) began its Phase 3 trial for urcosimod, a treatment for neuropathic corneal pain. The NEPTUNE study has started in the US and will expand to Europe. The trial aims to assess pain reduction and quality-of-life improvements over 12 weeks. OKYO claims urcosimod is the first potential disease-modifying treatment for this condition, which currently lacks FDA-approved therapies.

OKYO Pharma (OKYO) has started its Phase 3 NEPTUNE trial for urcosimod, a potential treatment for neuropathic corneal pain (NCP). The trial, enrolling patients in the U.S. and Europe, will evaluate the drug's efficacy over 12 weeks. Urcosimod targets the ChemR23 receptor and has shown promise in earlier studies. NCP lacks FDA-approved treatments, representing an unmet medical need. OKYO shares closed at $1.47 on Monday.

OKYO Pharma has begun enrolling patients in its Phase 3 NEPTUNE trial for urcosimod, a treatment for neuropathic corneal pain. The trial, with sites in the U.S. and Europe, is a key step for the company's lead asset, which targets a condition with no current FDA-approved therapies. A successful outcome could support a regulatory filing.

OKYO Pharma (NASDAQ:OKYO) said it received positive feedback from a US FDA Type D meeting for urcosimod, giving regulatory clarity for a global Phase 3 pivotal trial in neuropathic corneal pain. The company plans a single-dose Phase 3 study, the Neptune trial, enrolling about 111 patients with 0.05% urcosimod vs placebo (2:1). It is finalizing about 14 sites in the US and Europe and may seek Breakthrough Therapy designation.

OKYO Pharma said the FDA provided positive feedback in a Type D meeting for its investigational drug urcosimod for neuropathic corneal pain. The FDA endorsed a single-dose Phase 3 design and said a potential single-trial registration pathway could be considered if results support it. The NEPTUNE Phase 3 trial will enroll about 111 patients in the US and Europe.

OKYO Pharma (NASDAQ: OKYO) said the US FDA provided feedback in a Type D meeting supporting advancement of its investigational drug urcosimod into a global Phase 3 pivotal trial for neuropathic corneal pain. The NEPTUNE study will enroll about 111 patients in the US and Europe, randomizing 2:1 to 0.05% urcosimod or placebo. OKYO plans to seek Breakthrough Therapy Designation.