OKYO’s 0.05% Urcosimod Achieves −4.5 QoL Improvement in Phase 2a Trial
OKYO Pharma’s Phase 2a trial of 0.05% urcosimod in 12 neuropathic corneal pain patients showed mean improvements in enjoyment of life (−4.5 vs 0), mood (−1.5 vs −0.5), and time spent thinking about pain (−3.0 vs −1.5). Data also showed nerve-restoration signals and support planned Phase 2b/3 trials.
1. Phase 2a Trial Design
In an intent-to-treat population of 12 neuropathic corneal pain patients, the randomized, double-masked, placebo-controlled study evaluated topical 0.05% urcosimod (n=6) versus placebo (n=6) over 12 weeks, with primary pain reduction measured by VAS and secondary QoL endpoints on a 0–10 scale.
2. Quality-of-Life Improvements
Patients receiving urcosimod reported mean changes from baseline of −4.5 points in enjoyment of life (IQR −6.00 to −0.75) compared with 0 (IQR −4.75 to 1.25) for placebo, −1.5 versus −0.5 in mood, and −3.0 versus −1.5 in time spent thinking about eye pain.
3. Signal of Nerve Restoration and Next Trials
Exploratory outcomes suggested potential restoration of corneal nerve structure, reinforcing urcosimod’s holistic profile, and OKYO Pharma plans a multi-center Phase 2b/3 trial with approximately 150 subjects to confirm these findings in this therapy-naïve indication.