OKYO Pharma confirmed that the U.S. Food and Drug Administration approved the design of its planned Phase 2b/3 clinical trial for urcosimod, a topical therapy for neuropathic corneal pain. The Type C meeting held on January 28, 2026, resulted in FDA agreement that the primary endpoint—reduction in pain measured by the Visual Analogue Scale at Week 12—was clinically meaningful. The agency also endorsed the study’s sample size, powering assumptions, and the use of the Ocular Pain Assessment Survey as supportive quality‑of‑life evidence, indicating no material issues with the chemistry, manufacturing, and controls strategy.
The alignment de‑risks the program by confirming that the trial design meets regulatory expectations, a critical step toward potential approval. OKYO plans to launch a 120‑patient, multiple‑dose Phase 2b/3 study in the first half of 2026. The FDA’s endorsement supports the company’s strategy to accelerate the drug’s development timeline and positions urcosimod as a potential first‑in‑class treatment for a condition that currently has no approved therapies.
CEO Robert J. Dempsey said the meeting “reflects years of disciplined scientific and clinical execution; the FDA’s alignment on our Phase 2b/3 strategy meaningfully de‑risks the program and represents a meaningful value‑inflection point for urcosimod.” He added that the outcome is a “step forward for patients suffering from neuropathic corneal pain, where the unmet need remains profound.”
The FDA also provided guidance that, if the statistical analysis plan is finalized before unmasking and the results are strong, the data could support substantial evidence of effectiveness at a future End‑of‑Phase 2b/3 meeting. This suggests that OKYO’s urcosimod program could progress more quickly toward approval, potentially unlocking a first‑in‑class topical therapy for a condition with no FDA‑approved treatments.
Analysts note that the company’s financial outlook includes expected earnings declines in the coming years, but significant revenue growth is projected. The regulatory milestone is a key driver of investor confidence, as it reduces uncertainty around the trial’s design and increases the likelihood of a favorable regulatory outcome.
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