According to the company, study enrollment is planned to commence during Q1 2024 following IND allowance by the FDA.
OKYO Pharma has announced it has filed an Investigation 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, study enrollment is planned to commence during Q1 2024 following IND allowance by the FDA.1
With no FDA-approved drug to treat NCP, OKYO stated in a press release that this remains a major unmet medical need for the ocular community.1
“The open-label trial 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,” said the company in the release.
Pedram Hamrah, MD, 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, will lead the NCP trial according to OKYO. Hamrah, a leading expert in NCP and co-inventor on the OK-101 patent, is a member of OKYO’s scientific advisory board and plants to serve as principal investigator of the study that will be held at Tufts Medical Center.1
“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 Hamrah in the release. “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 Gary S Jacob, PhD, CEO of OKYO.
OK-101 is also being tested for the treatment of dry eye disease, and is currently in a Phase 2, multicenter, double-masked, placebo-controlled trial.