Kiora Pharmaceuticals Receives Investigational New Drug Approval for Phase 2 Study of KIO-101
Wednesday, March 08, 2023
Kiora Pharmaceuticals announced 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 enrol 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 consisting of 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.
The Phase 2 study of KIO-101 is a multicenter, randomised, controlled, double-masked clinical trial in up to 120 patients with ocular signs and symptoms and diagnosed autoimmune diseases, including RA, psoriatic disease, systemic lupus erythematosus, or fibromyalgia. The study will evaluate two concentrations of KIO-101, 0.15 % and 0.30 %. The efficacy endpoints will evaluate a number of established ocular signs and symptoms, including but not limited to corneal staining and changes in the Schirmer's test score at 12 weeks. The study will also evaluate several safety and tolerability measures.
