OKYO Pharma Ltd (NASDAQ:OKYO), the clinical-stage drug developer, told investors it has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development of OK-101 to treat Neuropathic Corneal Pain (NCP).
According to the company, there is no FDA-approved drug to treat NCP, which remains a major unmet medical need for the ocular community. The trial provides the opportunity to establish OK-101’s potential to treat this condition, it added.
The open-label trial, to be led by Dr Pedram Hamrah, will provide an opportunity to evaluate the safety and efficacy of OK-101 for NCP in a real-world clinical setting, fostering a better understanding of its potential benefits for patients, OKYO added.
Hamrah is 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.
An ophthalmologist and a clinician-scientist, the company noted that Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is a member of OKYO’s Scientific Advisory Board and plans to serve as principal investigator of the study, which will be conducted at Tufts Medical Center.
“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,” Dr Hamrah commented.
“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.”
OKYO said it plans to commence enrollment in the study in the first quarter of 2024 following IND allowance by the FDA.
“We are excited about OK-101’s dual combination of anti-inflammatory ocular activity and NCP-reducing activity and are eager to evaluate this drug to treat NCP while awaiting the top-line data for OK-101 from the ongoing Phase 2 DED (dry eye disease) trial which is planned for released in December 2023,” OKYO CEO Dr Gary Jacob added.
Contact the author at stephen.gunnion@proactiveinvestors.com