OKYO Pharma Ltd (NASDAQ:OKYO) earlier this week announced the early termination of its Phase 2 trial evaluating urcosimod (formerly OK-101) for neuropathic corneal pain.
The company said the 48-patient study, which began in October 2024, was initially planned to continue through the end of the year. However, based on encouraging signals from blinded data, OKYO has opted to close the trial early and proceed with data unblinding.
The trial was structured as a double-masked, placebo-controlled, randomized study with three arms: placebo, 0.05% urcosimod, and 0.1% urcosimod.
OKYO told investors that neuropathic corneal pain is a debilitating eye condition involving severe nerve-based pain, with no current FDA-approved therapies. The company highlighted that patients in the trial had previously failed multiple treatments.
The company said it will now prepare for an End-of-Phase 2 meeting with the FDA to discuss the design of future registration trials. This is a required step before a potential New Drug Application (NDA) filing.
It also noted that a number of patients have requested compassionate use access to urcosimod. The company is working with the FDA to support this under expanded access provisions.
OKYO said unblinded data from the trial will inform its regulatory strategy and help define next steps in development.