Kyowa Kirin Co Ltd (TSE: 4151), a Japan-based Global Specialty Pharmaceutical Company, announced on Tuesday that it has enrolled its first subject in a phase two clinical trial, multi-centre, randomised, double-masked, parallel group study of tivozanib eye drops (KHK4951).

The study is to assess the efficacy and safety of KHK4951 in patients with diabetic macular edema (DME). KHK4951 is a novel nano-crystalised tivozanib eye drop designed for delivery to the posterior ocular tissues and is being developed as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and DME.

Presently, an oral formulation of tivozanib is marketed as FOTIVDA in the US by AVEO Oncology, an LG Chem Company, and in Europe by EUSA Pharma (UK) Ltd for another indication.

The Phase two study will be enrolling 150 subjects 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.