Kiora Pharmaceuticals Receives Investigational New Drug Approval for Phase 2 Study of KIO-101
Wednesday, February 08, 2023
Kiora Pharmaceuticals announced that it has received investigational new drug application approval for a Phase 2 study of KIO-101 for the treatment of the Ocular Presentation of Rheumatoid Arthritis and other autoimmune diseases (OPRA+). This study will enroll approximately 120 patients in a multi-centre, controlled, randomised, double-masked trial assessing the safety and efficacy of KIO-101 eye drops in patients living with autoimmune disease who have signs and symptoms of ocular surface disease. The study is expected to begin enrolling patients in Australia in the first half of 2023.
KIO-101 is a topical, patient-friendly eye drop with a proven mechanism of action in autoimmune diseases. This drug has the potential to finally close the wide gap of untreated ocular disease in patients with common autoimmune diseases.
KIO-101 is part of a class of non-steroidal autoimmune disease drugs called DHODH inhibitors, which reduces T-cell proliferation and ongoing proinflammatory cytokine release. KIO-101 has the potential to affect the local immune response in the eye responsible for the ophthalmic signs and symptoms of these autoimmune diseases. Of the autoimmune diseases that KIO-101 is targeting, the ocular manifestations are found in approximately 3.43 million patients in the U.S.
