OKYO Pharma FDA Type D meeting positive

OKYO Pharma Limited (Nasdaq: OKYO) announced positive feedback from its U.S. United States — Food and Drug Administration (FDA) Type D meeting, validating the regulatory and clinical path forward for urcosimod, a first-in-class investigational therapy for neuropathic corneal pain (NCP). The FDA endorsed a single-dose Phase 3 study design and indicated a potential single-trial registration pathway. OKYO unveiled the NEPTUNE trial, a global Phase 3 pivotal study enrolling approximately 111 patients in the United States and Europe, randomized 2:1 to receive 0.05% urcosimod or placebo. The company plans to seek FDA Breakthrough Therapy Designation to further accelerate development. Urcosimod has received Fast Track designation and is the first investigational therapy with an open IND for NCP, a debilitating condition with no FDA-approved treatments. The positive FDA feedback de-risks the development program and supports OKYO's accelerated clinical plan.