OKYO Pharma Ltd (NASDAQ:OKYO) said on Friday the US Food and Drug Administration has authorized a single-patient expanded access, or compassionate use, investigational new drug application for its experimental eye therapy urcosimod to treat neuropathic corneal pain.
The FDA authorization allows urcosimod, at a 0.05% dose, to be used in a patient with severe neuropathic corneal pain who has limited treatment options and no FDA-approved therapies available.
Neuropathic corneal pain is a chronic condition characterized by severe eye pain driven by immune-mediated inflammation and dysfunctional nerve signaling.
Hamrah said the authorization enables investigation of urcosimod’s proposed dual mechanism of action, which may target both inflammatory and nerve-related pathways involved in the condition.
OKYO said it will supply the drug under the FDA-authorized expanded access program.
CEO Robert Dempsey said the compassionate use authorization underscores the unmet need for treatments specifically targeting neuropathic corneal pain, a condition for which no FDA-approved therapies currently exist. “This also reflects the potential new hope for patients battling this debilitating painful condition with no FDA approved treatment available today,” Dempsey told shareholders.
OKYO previously received FDA authorization for an investigational new drug application for urcosimod in neuropathic corneal pain and was granted fast track designation. The company expects to begin a 120-patient Phase 2b/3 multiple-dose clinical trial of urcosimod later this year.