OKYO Pharma Announces Filing of an IND Application for OK-101 to Treat Neuropathic Corneal Pain
OKYO Pharma announced that it filed an investigational new drug (IND) application with the FDA for the development of OK-101 to treat Neuropathic Corneal Pain (NCP). Study enrollment is planned to commence during Q1 2024 following IND allowance by the FDA.
There is no FDA-approved drug to treat NCP. 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.
The NCP trial will be led by 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. An ophthalmologist and a clinician-scientist, Dr. Hamrah is an 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 said in a company news 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 topline data for OK-101 from the ongoing hase 2 DED trial which is planned for released in December 2023,” said Dr. Gary S. Jacob, CEO of OKYO.
About the OK-101 Phase 2 DED Trial Design
This phase 2, multicenter, randomized, double–blinded, placebo-controlled study is designed to enroll approximately 240 subjects with DED who are being randomly divided into 3 cohorts of 80 patients. Participants are being selected based on specific inclusion and exclusion criteria. The three cohorts include one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101. The drug and placebo, respectively, are being administered in both eyes twice daily for 12 weeks. The duration of a patient’s treatment is approximately 14 weeks, including a 2-week run-in period, to address the placebo effect, which is common for trials involving a pain component, followed by 12 weeks of treatment. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Further details regarding the specifics of the trial are posted on the clinicaltrials.gov public website (clinicaltrials.gov Identifier: NCT05759208 or https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).