USFDAJul 8, 2026, 07:02 AM
OKYO Pharma Gets Positive FDA Feedback for Urcosimod Phase 3 Trial
AI Summary
OKYO Pharma Ltd announced positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting for urcosimod, validating the regulatory and clinical path forward for the drug. This feedback supports the advancement of urcosimod into a global Phase 3 pivotal trial for Neuropathic Corneal Pain (NCP), with the FDA aligning on a single-dose Phase 3 study design and a potential single-trial registration pathway. The company plans to seek FDA Breakthrough Therapy Designation (BTD) for urcosimod, which already holds Fast Track designation, to address the significant unmet medical need for NCP.
Key Highlights
- OKYO Pharma received positive feedback from its FDA Type D meeting for urcosimod.
- The feedback validates the regulatory and clinical path forward for urcosimod in Neuropathic Corneal Pain (NCP).
- Company is advancing urcosimod into a global Phase 3 pivotal trial named NEPTUNE.
- FDA aligned on a single-dose Phase 3 study design and potential single-trial registration pathway.
- NEPTUNE trial will enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo.
- OKYO Pharma plans to seek FDA Breakthrough Therapy Designation (BTD) for urcosimod.
- Urcosimod previously received Fast Track designation from the FDA for NCP.
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