OKYO Pharma Begins First Clinical Trial for Neuropathic Corneal Pain Treatment

OKYO Pharma Limited has announced the successful dosing of the first patient in its Phase 2 clinical trial for OK-101, a groundbreaking non-opioid therapy designed to treat Neuropathic Corneal Pain (NCP). This condition, which can result from dry eye disease, surgery, or infections, causes severe pain and significantly impacts the quality of life for sufferers. Notably, there are currently no FDA-approved treatments available for this debilitating condition.

The Phase 2 study is structured as a randomized, double-masked, placebo-controlled trial, set to run over 12 weeks. A total of 48 patients, all confirmed to have NCP through confocal microscopy, will participate in this trial. OK-101 aims to address the severe pain associated with corneal nerve damage, offering a potential new avenue for treatment where only limited and temporary relief strategies currently exist.

The single-center trial is being conducted under the leadership of Dr. Pedram Hamrah of Tufts Medical Center, who serves as the Principal Investigator. Dr. Hamrah holds several esteemed positions at Tufts, including Professor and Vice Chair of Research and Academic Programs, and Director of the Center for Translational Ocular Immunology. His extensive research has contributed significantly to the understanding and treatment of ocular pain, leading to the development of new diagnostic markers for the condition.

In addition to his role in the OK-101 trial, Dr. Hamrah is actively involved in other pioneering studies aimed at developing new tests for corneal nerve function. His expertise in the field is further underscored by his position on OKYO’s Scientific Advisory Board and his co-inventor status for OK-101. Dr. Hamrah also plans to launch a center of excellence for ocular pain and surface disease at Tufts Medical Center.

Commenting on the trial's progress, Dr. Hamrah emphasized the importance of enrolling the first patient, marking a significant milestone in the quest to validate the safety and efficacy of OK-101. He highlighted the urgent need for an approved treatment for NCP, underscoring the global impact of this condition. The recruitment and rigorous evaluation of this therapy will continue in the coming weeks and months.

Dr. Gary S. Jacob, CEO of OKYO Pharma, expressed his enthusiasm over the advancement of the trial, noting that the enrollment of the first patient is a critical step towards addressing the unmet medical need for NCP treatments. He highlighted OK-101 as a potential breakthrough therapy that could transform the treatment landscape for patients suffering from chronic ocular pain.

OK-101 is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor on immune cells in the eye, which play a key role in the inflammatory response. Developed using membrane-anchored-peptide technology, OK-101 is a long-acting drug candidate designed not only to reduce pain but also to remain active within the ocular environment for extended periods. Preclinical studies have shown its efficacy in reducing both inflammation and pain in models of dry eye disease and corneal neuropathic pain.

OKYO Pharma Limited, listed on the NASDAQ Capital Market, focuses on developing innovative treatments for inflammatory dry eye disease (DED) and NCP. The company recently completed a Phase 2 trial of OK-101 for DED patients and continues to evaluate its potential for treating NCP through the newly initiated Phase 2 trial. This promising therapeutic candidate represents a significant step forward in providing new treatment options for patients with these challenging ocular conditions.