First patient dosed in clinical trial to treat neuropathic corneal pain

(Image credit: Adobe Stock/Evgina_lo)

OKYO Pharma Ltd today announced the first patient has been dosed in the Phase 2 trial of topical ocular OK-101 to treat NCP.

The Phase 2 clinical trial of OK-101 is a double-masked, randomized, 12-week placebo-controlled study in patients with neuropathic corneal pain (NCP), according to the company. The study aims to enroll 48 patients, with NCP diagnosis confirmed via confocal microscopy. OK-101, a novel non-opioid therapeutic candidate, is designed to address the severe pain associated with corneal nerve damage—a condition for which there are currently no FDA-approved treatments. NCP, often linked to dry eye disease, surgical interventions, or infections, significantly impacts patient quality of life, with current management options providing only partial or temporary relief.¹

In preclinical studies, OK-101 has demonstrated anti-inflammatory and pain-relieving effects in mouse models of dry eye disease and NCP. A key feature of OK-101 is its lipid anchor, designed to prolong the drug's residence time in the ocular environment, combating the washout effect. The drug showed statistically significant results across multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial for dry eye disease.

The OK-101 trial is being conducted at a single center, led by principal investigator Pedram Hamrah, MD, at Tufts Medical Center. Hamrah, professor and vice chair of Research and Academic Programs and director of the Center for Translational Ocular Immunology, has extensive experience in ocular pain research. His previous work has demonstrated the safety and efficacy of various topical and systemic treatments for ocular pain and contributed to the development of new diagnostic markers for ocular pain using in vivo confocal microscopy.

In addition to his involvement with OK-101, Hamrah, a co-inventor of the drug and member of OKYO Pharma's scientific advisory board, is advancing research on new corneal nerve function tests. He is also planning to establish a center of excellence for ocular pain and ocular surface disease at Tufts Medical Center.

"Enrolling the first patient in this clinical trial is a critical milestone in our efforts to evaluate the safety and efficacy of OK-101 for NCP treatment," Hamrah said in a news release. "There is an urgent need for an approved therapy to relieve eye pain in NCP patients worldwide. We are committed to advancing patient recruitment and rigorously assessing this experimental therapy."

OKYO Pharma CEO, Gary S. Jacob, PhD, added, "We are excited to announce the enrollment of the first patient in our Phase 2 clinical trial of OK-101. This is an important step towards providing relief for patients suffering from neuropathic corneal pain, a chronic condition for which there are currently no FDA-approved treatments.

Reference

1. OKYO Pharma LTD. OKYO Pharma Announces First Patient Dosed in the First Clinical Trial to Treat Neuropathic Corneal Pain. GlobeNewswire News Room. Published October 23, 2024. Accessed October 23, 2024. https://www.globenewswire.com/news-release/2024/10/23/2967620/0/en/OKYO-Pharma-Announces-First-Patient-Dosed-in-the-First-Clinical-Trial-to-Treat-Neuropathic-Corneal-Pain.html