Investing.com -- OKYO Pharma Limited (NASDAQ:OKYO) stock climbed 4.7% Wednesday after the company announced successful discussions with the FDA regarding its Phase 2b/3 clinical trial design for urcosimod, a treatment for neuropathic corneal pain (NCP).
The London and New York-based biopharmaceutical company received confirmation from the FDA that its proposed primary endpoint of Visual Analogue Scale pain reduction at Week 12 is clinically meaningful. The agency specifically acknowledged that a 2-point or greater improvement on the VAS scale represents a meaningful treatment effect.
The FDA also endorsed OKYO’s proposed study design, sample size, and powering assumptions, while agreeing that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence. Additionally, the agency aligned with the company’s Chemistry, Manufacturing and Controls strategy.
"This alignment represents an important step forward and underscores the potential to address a significant unmet medical need in patients with neuropathic corneal pain," said Raj Patil, Chief Scientific Officer at OKYO Pharma.
The company plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year. Urcosimod previously received fast track designation from the FDA and was granted the first Investigational New Drug application to treat patients with NCP.
OKYO Pharma focuses on developing therapies for the treatment of neuropathic corneal pain and inflammatory eye diseases.
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