Okyo Pharma initiates phase 2 trial of OK-101 for neuropathic corneal pain
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Okyo Pharma has announced that screening and recruitment has been initiated for a phase 2 trial of OK-101 to treat neuropathic corneal pain, with plans to enroll 48 patients, according to a company press release.
“The initiation of this trial of topically applied OK-101 to treat [neuropathic corneal pain (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,” Gary S. Jacob, PhD, Okyo’s CEO, said in the release. “Importantly, this clinical study is a follow-on to the completion of a 240-patient trial of OK-101 in dry eye disease patients, and the results from that trial showed statistical significance in reducing ocular pain.”
According to the release, OK-101 significantly reduced neuropathic corneal pain in preclinical studies, in addition to demonstrating favorable safety and tolerability and symptom improvement in a phase 2 trial of patients with dry eye disease.
The current 12-week, double-masked, randomized, placebo-controlled, single-center trial includes patients with NCP confirmed through confocal microscopy, with the primary endpoint of pain relief measured via the Visual Analog Scale.
“I am looking forward to rigorously evaluating OK-101’s potential in treating pain symptoms in patients suffering from neuropathic corneal pain,” Pedram Hamrah, MD, principal investigator and director of the Center for Translational Ocular Immunology at Tufts Medical Center, said in the release. “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.”
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