OKYO Pharma (OKYO) Corporate presentation summary

Urcosimod and unmet need

• Urcosimod is a preservative-free, non-opioid 0.05% eye drop targeting ChemR23, with proposed dual pain-relieving and anti-inflammatory activity for neuropathic corneal pain (NCP).

• NCP can cause severe pain, light and wind sensitivity, burning, and foreign-body sensation; diagnosis is challenging and there are no FDA-approved treatments.

• Current management is limited to short-term NSAIDs, steroids, and opioids in severe cases; delayed or incorrect diagnosis can allow pain to become centralized and harder to treat.

Clinical evidence

• In a Phase 2a NCP study, 75% of per-protocol patients on 0.05% urcosimod achieved >80% pain reduction after 12 weeks; mean VAS improvement was 5.5 points versus 2.75 for placebo.

• Pain improvement was observed by Week 4 and sustained through Week 12; a moderate-to-severe baseline pain subgroup showed a 5.2-point change with urcosimod versus 1.7 points with placebo at Week 12.

• The Phase 2a trial planned 48 subjects, randomized 18, and ended early for operational reasons; no drug-related SAEs were reported, and most AEs were mild stinging or burning.

• Phase 2a exploratory imaging showed median changes of +2.0 in total nerve fiber count and +2.6 in nerve fiber length with urcosimod, versus -1.92 and -1.63 with placebo; nerve-length comparison p=0.057.

• In a 240-subject Phase 2 dry-eye study, no severe adverse events were reported; pain relief and safety findings supported further NCP development.

Phase 3 and milestones

• NEPTUNE began enrolling patients in 2026; the Phase 3 trial plans ~111 adults, randomized 2:1 to 0.05% urcosimod or placebo for 12 weeks.

• Primary endpoint is ocular pain reduction on a 10-point VAS at Week 12; FDA agreed that a ≥2-point improvement versus placebo is clinically meaningful and label-enabling.

• Topline NEPTUNE data are expected in 4Q27; the presentation also targets enrollment completion in 2Q27.

• A commercial-grade clinical lot was produced for NEPTUNE, and the development plan includes corneal nerve imaging as an exploratory endpoint.