Kiora Pharmaceuticals, Inc. 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 enroll approximately 120 patients in a multi-center, controlled, randomized, 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.
“Ocular surface disease is the most common non-joint manifestation of patients living with Rheumatoid Arthritis (RA) as well as other common autoimmune diseases,” said Eric Daniels, M.D., Chief Development Officer of Kiora. “While the systemic treatment of underlying autoimmune diseases has advanced dramatically in the past decade, these agents commonly do not address local ocular disease. This unfortunately leaves affected autoimmune patients with few available eye drug options that only offer limited relief in addressing the moderate to severe ocular dryness, pain and discomfort associated with these diseases. KIO-101 is a topical, patient-friendly eye drop with a proven mechanism of action in autoimmune diseases. Proof-of-concept has been established in previous ocular inflammation clinical studies for KIO-101. 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 reduce T-cell proliferation and ongoing proinflammatory cytokine release. Approved systemic drugs in this class, which target systemic disease, generate about $2B in annual revenue. 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.
The Phase 2 study of KIO-101 is a multicenter, randomized, 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.