OKYO Pharma Ltd (NASDAQ:OKYO) has revealed a new partnership with Tufts Medical Center to conduct an open-label clinical trial to assess the efficacy and safety of OK-101 in treating patients with neuropathic corneal pain (NCP).
NCP is a distressing condition that causes chronic and severe eye discomfort, severely impacting the quality of life for those affected.
The Investigational New Drug (IND) application for NCP is scheduled to be submitted in the fourth quarter of 2023, with patient enrollment expected to begin soon after receiving approval from the US Food & Drug Administration (FDA).
OK-101, an innovative investigational therapeutic developed by OKYO Pharma, offers a promising solution to alleviate NCP symptoms. This real-world clinical trial will provide an opportunity to better understand the drug's potential benefits for patients.
In a statement, Dr Gary S. Jacob, CEO of OKYO, expressed excitement about OK-101's anti-inflammatory ocular activity and its potential to reduce NCP. He noted: "NCP has gained considerable significance this past year as a major unmet medical need for patients specifically diagnosed with this debilitating ocular condition."
Dr Pedram Hamrah, a leading expert in NCP and co-inventor of the OK-101 patent, will lead the trial. As a member of OKYO’s Scientific Advisory Board, Dr Hamrah plans to serve as the Principal Investigator for the study, which will take place at Tufts Medical Center. This collaborative effort aims to evaluate OK-101 as a potential non-opioid analgesic for neuropathic corneal pain, addressing a significant unmet medical need.
Dr Hamrah commented: "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."
Preclinical studies using a mouse model of NCP have demonstrated the potential of OK-101 as a topical non-opioid analgesic. The drug showed a reduced corneal pain response similar to gabapentin, a commonly used oral drug for NCP. The current treatments for NCP are limited to short-term NSAIDs, steroids, oral gabapentin, and, in severe cases, opioids, which come with significant side effects and risk of addiction.
OK-101 is currently undergoing a Phase 2 clinical trial for the treatment of dry eye disease. The company is optimistic about the drug's potential to address inflammatory dry eye diseases and chronic pain, paving the way for improved therapeutic options for patients in need.
Contact the author at jon.hopkins@proactiveinvestors.com