OKYO Pharma’s Phase 2 trial of urcosimod for neuropathic corneal pain (NCP) yielded positive top-line results. The trial involved 18 patients and showed a marked reduction in pain scores, with 75% of the per-protocol group receiving 0.05% urcosimod achieving over 80% pain reduction after 12 weeks. Importantly, these patients had moderate to severe NCP despite prior treatments, highlighting the unmet need addressed by urcosimod.
This positive data is a significant advancement in ophthalmology. Currently, no FDA-approved treatment exists for NCP, leaving patients with limited options for managing this chronic and debilitating condition. Urcosimod’s efficacy offers hope for a targeted therapy, potentially improving the quality of life for those suffering from this painful condition. The rapid onset of pain reduction observed as early as Week 4 further underscores the drug’s potential to provide timely relief.
The Phase 2 trial, though conducted at a single site and initially planned for 48 patients, was closed early at 18 patients to expedite data analysis. The 0.05% urcosimod group demonstrated a statistically significant reduction in mean pain scores (p-value = 0.025). While the placebo group also showed improvement, the magnitude of change was half that observed in the urcosimod group, and the placebo group’s baseline pain scores were milder. The intent-to-treat population analysis further corroborated these findings, showing 67% of the 0.05% urcosimod group achieving greater than 50% pain improvement versus 33% in the placebo group. No serious adverse events were reported. OKYO plans to discuss next steps with the FDA, leveraging the drug’s Fast Track designation.
These results pave the way for further clinical development of urcosimod. The data suggests this drug could be a first-in-class treatment for NCP, addressing a substantial unmet medical need. While further research is needed, the positive Phase 2 results indicate a promising future for urcosimod and offer potential relief to patients suffering from NCP. The company’s plans to meet with the FDA and potentially offer expanded access further reinforces their commitment to bringing this therapy to market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
