Kyowa Kirin Co., Ltd. announced the enrollment of the first patient in a Phase 2 clinical trial, multi-center, randomized, double-masked, parallel group study of tivozanib eye drops (KHK4951). This study investigates the efficacy and safety of KHK4951 in patients with diabetic macular edema (DME). Tivozanib, the active ingredient of KHK4951 is a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) discovered and developed by Kyowa Kirin.

KHK4951 is a novel nano-crystalized tivozanib eye drops designed to deliver it efficiently to the posterior ocular tissues and is being developed as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and DME. An oral formulation of tivozanib is currently marketed as FOTIVDA? in the U.S. by AVEO Oncology, an LG Chem Company, and in Europe by EUSA Pharma (UK) Ltd. for another indication.

The Phase 2 study will be recruiting 150 patients with DME across the US, Japan, Australia and South Korea. The primary outcome measure is reduction of 15 or more letters from baseline in BCVA (Best Corrected Visual Acuity) as measured by the ETDRS visual acuity chart. A separate Phase 2 study to evaluate KHK4951 in patients with neovascular(wet) age-related macular degeneration(nAMD) is also being initiated.

This study is currently recruiting patients. The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.