OKYO Pharma Files IND Application for OK-101 to Treat Neuropathic Corneal Pain
OKYO Pharma Limited, a clinical stage biopharmaceutical company, has announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the development of OK-101 to treat Neuropathic Corneal Pain (NCP). NCP is a severe ocular condition with no FDA approved therapy, making it a major unmet medical need. The filing of the IND application marks an important step towards addressing this condition and potentially providing relief to patients suffering from NCP.
The IND application allows OKYO Pharma to initiate the enrollment of patients for a clinical trial to evaluate the safety and efficacy of OK-101 for NCP. The trial will be led by Dr. Pedram Hamrah, a leading expert in NCP and a member of OKYO’s Scientific Advisory Board. Dr. Hamrah plans to serve as the Principal Investigator of the study, which will be conducted at Tufts Medical Center.
Currently, NCP is treated with various off-label topical and systemic treatments, as there are no approved commercial treatments available. The clinical trial aims to investigate the potential efficacy of OK-101 in treating the symptoms of NCP. OK-101 is a lipid conjugated chemerin peptide agonist designed to combat inflammation and reduce pain associated with NCP. It has shown promising results in mouse models of dry eye disease and corneal neuropathic pain.
In addition to the NCP trial, OKYO Pharma is also conducting a Phase 2 trial of OK-101 to treat inflammatory dry eye disease (DED). The company is eagerly awaiting the top-line data from this trial, which is expected to be released in December 2023.
OKYO Pharma is dedicated to developing innovative therapies for inflammatory DED and ocular pain. The company’s focus on addressing unmet medical needs in the ophthalmic field highlights its commitment to improving the lives of patients suffering from these conditions.
For more information about OKYO Pharma and its ongoing clinical trials, please visit www.okyopharma.com.