Workflow
OKYO Pharma CEO details positive results from Phase 2 urcosimod trial - ICYMI
OKYO PharmaOKYO Pharma(US:OKYO) Proactiveinvestors NAยท2025-07-19 15:51

Core Insights - OKYO Pharma Ltd has announced significant topline data from its Phase 2 trial of urcosimod for treating neuropathic corneal pain, a condition with no FDA-approved treatments [1][4][11] - The trial was randomized, placebo-controlled, and involved 48 patients, with confocal microscopy used to confirm the presence of neuropathic pain [1][8][10] - The study was halted early after 17 patients completed 12 weeks of treatment due to notable pain reduction in those receiving urcosimod topically [2][10] Company Overview - OKYO Pharma is pioneering the development of the first drug specifically targeting neuropathic corneal pain, which is described as severe nerve pain comparable to having a spinal cord injury in the eye [5][11] - The company has received fast track designation from the FDA, allowing for an accelerated development process towards drug approval [11][12] Clinical Trial Details - The Phase 2 trial commenced in October and was designed to ensure that participants had neuropathic pain rather than inflammatory pain [8][9] - The decision to stop the trial early was made to assess the drug's effectiveness sooner, with the aim of moving forward with discussions with the FDA based on the preliminary data [10][12][13] Future Steps - Following the positive data from the trial, the company plans to approach the FDA to discuss the next stages of development for urcosimod [11][12] - The urgency in halting the trial early reflects the company's commitment to addressing the needs of patients suffering from a condition with no current approved treatments [14]