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.
Management highlighted the FDA's decision as an important step in providing potential relief for patients with severe NCP and reinforcing urcosimod's development trajectory in ophthalmology.
Additional details on the Phase 2b/3 study design, timeline, and regulatory strategy will be provided as planning progresses.