OKYO Pharma (NASDAQ:OKYO) announced that the U.S. Food and Drug Administration has authorized a single-patient expanded access Investigational New Drug application (IND 176297) for urcosimod 0.05% to treat a patient with severe neuropathic corneal pain (NCP).
The company stated that urcosimod will be provided under a physician-sponsored compassionate use protocol enabled by the expanded access authorization.
Urcosimod previously received FDA Fast Track designation for the treatment of neuropathic corneal pain, underscoring its potential to address a significant unmet need in this debilitating ocular condition.
OKYO expects to initiate a 120-patient Phase 2b/3 multiple-dose clinical study of urcosimod for NCP in 2026, building on the expanded access experience and prior clinical data to support potential registration.
Neuropathic corneal pain is a chronic, severe ocular surface disorder characterized by persistent pain disproportionate to clinical signs, often resistant to conventional therapies.
The expanded access pathway allows the patient to receive urcosimod outside of a controlled clinical trial while the company advances its broader development program.