Jan. 28 at 8:33 PM
OKYO Pharma reported successful discussions with the FDA regarding the design of its Phase 2b/3 clinical trial for urcosimod, a treatment for neuropathic corneal pain. The FDA confirmed that the proposed primary endpoint—a reduction in pain on the Visual Analog Scale at Week 12—is clinically meaningful, recognizing a two-point or greater improvement as a significant treatment effect. The agency also supported the trial design, sample size, statistical assumptions, and the use of an ocular pain assessment as supportive quality-of-life evidence, while aligning with the company’s CMC strategy. OKYO plans to launch a 120-patient Phase 2b/3 multiple-dose study in the first half of the year.
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