OKYO Pharma Files IND Application for OK-101 to Treat Neuropathic Corneal Pain

OKYO Pharma announced the submission of an Investigational New Drug (IND) application to the US FDA for the purpose of advancing the development of OK-101, a potential treatment for Neuropathic Corneal Pain (NCP). The initiation of study enrollment is scheduled for the first quarter of 2024, contingent upon the FDA granting permission for the IND application.

Neuropathic Corneal Pain (NCP) stands as a significant unmet medical need within the ocular community, given the absence of an FDA-approved medication for this condition. This clinical trial offers a unique opportunity to assess OK-101's capacity to address this medical issue.

The trial, which is open-label in nature, will enable an evaluation of the safety and effectiveness of OK-101 in the real-world clinical context, thereby contributing to a more comprehensive comprehension of its potential advantages for patients.

The leadership of the NCP trial will be entrusted to Dr. Pedram Hamrah, MD, who holds the positions of Professor, 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. Dr. Hamrah, a distinguished ophthalmologist and clinician-scientist, is an eminent authority on NCP and one of the co-inventors of the OK-101 patent. He also serves as a member of OKYO's Scientific Advisory Board and intends to assume the role of Principal Investigator for 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,” said Dr. Hamrah. “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.”

“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 trial which is planned for released in December 2023,” said Dr. Gary S. Jacob, CEO of OKYO.