OKYO Pharma CEO Gary Jacob joined Steve Darling from Proactive to share the top-line results from the recently completed Phase 2 trial of urcosimod, the company’s drug candidate for the treatment of Neuropathic Corneal Pain (NCP). The 18-patient, randomized, double-masked, placebo-controlled study was conducted at Tufts Medical Center under the direction of Dr. Pedram Hamrah, a leading expert in NCP.
Jacob noted that OKYO is the first company to conduct a clinical trial specifically targeting NCP, a serious and underserved condition with no approved treatments. The results showed that after 12 weeks of treatment, 75% of patients in the per-protocol group receiving 0.05% urcosimod experienced more than an 80% reduction in pain, as measured by the Visual Analogue Scale (VAS). Patients began to see meaningful improvement as early as Week 4, with effects sustained through the study’s conclusion.
The company also reported a statistically significant reduction in mean pain scores between the initial and final visits in the treatment group. All responders had entered the trial with moderate to severe pain despite previous use of maximum medical therapy.
Importantly, no serious adverse events were reported among the 18 participants, underscoring the favorable safety profile of urcosimod. With Fast Track designation already granted by the FDA, OKYO Pharma plans to meet with the agency to discuss the next steps in urcosimod’s regulatory pathway, potentially accelerating the development timeline for this novel treatment.