Okyo Pharma's Phase 2 Trial for Neuropathic Corneal Pain

Okyo Pharma announced its plan to initiate a phase 2 clinical trial for OK-101 in the treatment of neuropathic corneal pain (NCP), scheduled to begin in the third quarter of 2024. This one-year study follows promising results from preclinical animal models and the successful completion of OK-101's initial human trial in patients with dry eye disease (DED), demonstrating statistically significant pain relief.

Leadership and Oversight by Dr. Pedram Hamrah, MD

The phase 2 trial will be conducted at a single center and overseen by Dr. Pedram Hamrah, MD, a prominent ophthalmologist and clinician-scientist at Tufts Medical Center. Dr. Hamrah, who serves as Professor and Vice Chair of Research and Academic Programs, as well as Director of the Cornea Service and the Center for Translational Ocular Immunology at Tufts Medical Center, is also a co-inventor on the OK-101 patent and a member of Okyo's Scientific Advisory Board.

"I am looking forward to rigorously evaluating OK-101’s potential in treating pain symptoms in patients suffering from neuropathic corneal pain," said Dr. Hamrah in a company news 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."

Dr. Gary S. Jacob, PhD, CEO of Okyo Pharma, expressed confidence in OK-101's prospects, highlighting its role as the first NCP drug candidate to receive FDA Investigational New Drug (IND) clearance. "The favorable improvements in ocular pain in dry eye patients, some of whom suffer from NCP, coupled with impressive preclinical model results, are encouraging as we anticipate positive outcomes in our upcoming phase 2 trial for NCP," Dr. Jacob stated. "OK-101 targets a receptor found in neurons and glial cells, addressing a significant unmet need in ophthalmic care."

Phase 2 NCP Study Design and Endpoint

The phase 2 NCP study is designed as a double-masked, randomized, 12-week placebo-controlled trial involving 48 NCP patients diagnosed using confocal microscopy. The primary endpoint will assess pain improvement measured by Visual Analog Scale (VAS) compared to placebo. The trial will span five study visits over 16 weeks, including a follow-up visit four weeks post-completion.

Positive Results from Phase 2 DED Trial

In the recently completed phase 2 trial for DED patients, OK-101 demonstrated statistically significant and sustained improvements in pain, blurred vision, and burning/stinging sensations as early as Day 15 and continuing through Day 85. Patient-reported daily diaries also indicated significant pain score improvements within the first two weeks of treatment and sustained through the trial period. Additionally, OK-101 exhibited comparable efficacy to gabapentin in reducing corneal pain response in a preclinical mouse model by Day 14 post-surgery.

The initiation of the phase 2 NCP trial marks a significant advancement in Okyo Pharma's commitment to addressing the complexities of neuropathic corneal pain, potentially paving the way for a novel therapeutic option in ophthalmic medicine.