The trial will be an open-label trial in partnership with Tufts Medical Center. OK-101 is also being developed for use in dry eye disease.
OKYO Pharma has announced plans to initiate an open-label trial of OK-101 in patients with neuropathic corneal pain (NCP) after an agreement was made with Tufts Medical Center. OKYO has been developing OK-101 to treat dry eye disease (DED).
According to a press release from the company,1 the trial will be a 40-patient open-label clinical trial evaluating the efficacy and safety of OK-101 in patients with NCP. The company described NCP as “a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals.”
An Investigational New Drug (IND) application for NCP is planned to be filed in Q4 of 2023 according to the company, with study enrollment planned to commence shortly after IND allowance from the FDA.
Furthermore, the trial is expected to take 6 to 9 months to conduct with an estimated cost of just under $1 million.1
This NCP trial will be led by Pedram Hamrah, MD, professor and vice chair of research and academic programs, co-director of the cornea service and director of the center for translational ocular immunology at Tufts Medical Center. Hamrah is a co-inventor on the OK-101 patent.
“NCP, which can exhibit as a severe, chronic or debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion,” said Hamrah. “However, there are no approved commercial treatments currently available for this condition, and consequently we are looking forward to initiating the clinical trial to investigate the potential efficacy of OK-101 to treat symptoms of NCP.”
Using a mouse model of NCP, OK-101 when administered topically to mice, demonstrated a reduced corneal pain response similar to gabapentin when administered by intraperitoneal injection. According to the company, current treatments for NCP are limited to short-term NSAIDs, steroids, oral gabapentin and, in severe cases, opioids.1
“We are excited about OK-101’s dual combination of anti-inflammatory ocular activity and NCP reducing activity and are eagerly awaiting the top-line data from the DED trial,” said Gary S. Jacob, PhD, CEO of OKYO. “But we are also eager to move forward with our plan to evaluate this drug to treat NCP, which has gained considerable significance this past year as a major unmet medical need for patients specifically diagnosed with this debilitating ocular condition.”
Currently, OK-101 is in a Phase 2, multicenter, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED.