OKYO Pharma (LSE:OKYO) received constructive feedback from a U.S. Food and Drug Administration Type D meeting that validates the design of its planned Phase 3 pivotal study of urcosimod in neuropathic corneal pain (NCP), a chronic eye condition for which no FDA-approved therapy currently exists.
The clinical-stage biopharmaceutical company will advance directly into the NEPTUNE trial, a global study across the United States and Europe enrolling approximately 111 subjects in a 2:1 randomisation of 0.05% urcosimod versus placebo.
FDA alignment on a single-dose study design opens the door to a potential single-trial registration strategy, subject to successful results and continued agency review.
OKYO also intends to seek FDA Breakthrough Therapy Designation, which could further compress the development and review timeline.
Urcosimod holds Fast Track designation and carries the first open investigational new drug application specifically targeting NCP.
"The FDA's feedback provided regulatory validation of our upcoming NEPTUNE clinical trial design, accelerating both the clinical development plan for urcosimod and our ability to generate meaningful data for patients, physicians, and regulators," said Flavio Mantelli, Chief Medical Officer.
CEO Robert Dempsey added that a strong balance sheet supports moving directly into the global Phase 3 study.
