KYO Pharma (NASDAQ:OKYO) reported new exploratory Phase 2a findings for its lead candidate, urcosimod (0.05%), demonstrating that the topical therapy significantly improves the quality of life (QoL) for patients suffering from neuropathic corneal pain (NCP).
The randomized, double-masked, placebo-controlled study focused on patient-reported outcomes over a 12-week treatment period, revealing holistic benefits beyond simple pain reduction.
In a subset of 12 patients (6 urcosimod, 6 placebo), those treated with urcosimod showed a mean improvement of -4.5 in "enjoying life and relationships" on a 0–10 scale, compared to no change in the placebo group.
Mood scores improved by a mean of -1.5 for urcosimod versus -0.5 for placebo, and the time patients spent thinking about their eye pain decreased by a mean of -3.0, doubling the -1.5 improvement seen with the placebo.
These findings build on previous data where urcosimod achieved a 5.5-point reduction in pain severity and showed early signs of corneal nerve fiber restoration.
NCP is a debilitating chronic condition with no currently FDA-approved treatments, often leaving patients to rely on off-label medications with limited success.
Urcosimod, a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, is designed to address both the underlying inflammation and the nerve-related pain signals.
The drug has already received FDA Fast Track designation, reflecting its potential to fill a significant unmet medical need in the ophthalmic space.
Management plans to present the full data set at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting in May.
Building on these proof-of-concept results, OKYO is preparing to initiate a larger, multicenter Phase 2b/3 study involving approximately 150 patients in the first half of 2026.