OKYO Pharma (LSE:OKYO) said on Tuesday that the first patients have been enrolled in its Phase 3 NEPTUNE trial of urcosimod, its investigational topical therapy for neuropathic corneal pain (NCP).
The London-listed clinical-stage biopharmaceutical company is developing urcosimod for the chronic, often severe eye condition, which is thought to arise from damage or dysfunction of the corneal sensory nerves and currently has no FDA-approved treatment.
Dr. Melissa Toyos enrolled the first patients at the Toyos Clinic in Nashville, Tennessee, with further sites set to open across leading U.S. medical centres and in Europe, including Italy, Spain and France.
"Neuropathic corneal pain is one of the most debilitating conditions I see in my practice, and right now we have no FDA approved therapy to offer these patients, many of whom have tried everything and are still suffering," said Toyos.
The NEPTUNE trial is designed as a registrational study under FDA guidance, with patients receiving four drops of urcosimod daily for 12 weeks and the primary endpoint measuring change in ocular pain on a visual analogue scale, alongside quality-of-life scores and in-vivo confocal microscopy findings.
OKYO moved directly into the global Phase 3 programme after constructive feedback from an FDA Type D meeting validated its single-dose trial design, a pathway the company says could support a single-trial registration strategy if NEPTUNE delivers positive results.
The trial is planned to enrol approximately 111 subjects, randomised 2:1 between 0.05% urcosimod and placebo.
"The activation of the first site and initiation of OKYO's NEPTUNE trial represent an important milestone for building the clinical evidence necessary to support the potential first disease modifying treatment for neuropathic corneal pain," said Flavio Mantelli, Chief Medical Officer of OKYO Pharma.