Okyo Pharma Ltd announced in a press release new analyses of corneal images from the recently completed placebo-controlled, randomized, double-masked, phase 2 clinical trial of urcosimod in neuropathic corneal pain (NCP). Patients treated with 0.05% urcosimod demonstrated a positive reduction in neuropathic corneal pain, and favorable changes in corneal nerve structure that were not observed in the placebo group, the company said. 

Data compiled from nerve growth analyses that were an exploratory endpoint in the recently completed 18-patient trial of urcosimod demonstrated a favorable impact on corneal nerve health, noted the company. Patients treated with 0.05% urcosimod showed median increases in total nerve fiber count (+2.0, n/0.16 mm², Inter Quartile Range (IQR) 0.54 to 3.63) and total nerve fiber length (+2.6 mm/mm², IQR 1.55 to 5.67; P=.057 vs placebo). In contrast, the placebo group exhibited median decreases in total nerve fiber count (–1.92, n/0.16 mm², IQR –2.79 to –0.04) and total nerve fiber length (–1.63 mm/mm², IQR –3.76 to 0.63).

According to Okyo Pharma, this exploratory dataset, exhibiting consistent and meaningful directional improvements for 0.05% patients on urcosimod across key anatomical endpoints, highlights urcosimod’s potential to support corneal nerve restoration and reinforces its promise as a first-in-class therapeutic approach for neuropathic corneal pain that warrants further investigations. All values represent median (n=4).