OKYO Pharma Ltd (NASDAQ:OKYO) has started recruiting patients for its Phase 2 trial of its ocular therapy OK-101, aimed at treating neuropathic corneal pain (NCP).
The trial comes as part of OKYO’s broader efforts to address unmet needs in the billion-dollar inflammatory dry eye disease (DED) market and NCP, an eye condition characterized by severe eye pain and sensitivity with no approved therapies.
Both conditions are currently treated only with off-label medications.
The Phase 2 trial will be a double-masked, randomized, 12-week study involving 48 patients. The primary objective is to measure pain relief using the Visual Analog Scale (VAS).
OKYO’s clinical study builds on the recently completed 240-patient trial of OK-101 for dry eye disease, which demonstrated statistically significant reductions in ocular pain.
“The initiation of this trial of topically applied OK-101 to treat NCP marks a significant step forward for the company as we have been laser focused on moving this drug candidate into a clinical trial to treat NCP over the last 12 months,” said Gary Jacob, CEO of OKYO Pharma in a statement.
“We are eager to evaluate its potential benefits in patients with NCP.”
The trial is being conducted at Tufts Medical Center, led by Dr Pedram Hamrah, a leading expert in NCP and co-inventor of the OK-101 patent.
Hamrah expressed optimism about the trial's design, developed in consultation with the U.S. Food and Drug Administration (FDA). “We have designed an effective protocol to test our hypothesis in this patient population after productive FDA interactions and we will be closely overseeing the conduct of this trial at Tufts Medical Center,” Hamrah said.
OK-101, a lipid-conjugated chemerin peptide agonist, was developed to combat inflammatory eye conditions and is built to extend its residence time in the ocular environment. The drug has shown promise in animal models for reducing neuropathic corneal pain, and it recently demonstrated safety and efficacy in a Phase 2 trial for dry eye disease, with significant improvements in symptoms such as ocular pain and stinging.
Neuropathic corneal pain affects patients with a range of ophthalmic conditions, but no commercially approved treatments exist. The company is hopeful that OK-101 will address this unmet medical need as it advances through clinical trials.