Japanese speciality pharmaceutical company Kyowa Kirin has enrolled the first patient in a Phase 2 clinical trial of tivozanib eye drops (KHK4951) in patients with diabetic macular edema (DME).

Discovered and developed by Kyowa Kirin, tivozanib is the active ingredient of KHK4951. It is a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI).

The nano-crystalised tivozanib eye drops are designed to efficiently distribute the medication to the posterior ocular tissues.

The speciality pharmaceutical firm is developing the eye drops as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and DME.

AVEO Oncology, an LG Chem company, is presently marketing an oral formulation of tivozanib under the brand name Fotivda in the US. EUSA Pharma (UK) is marketing it in Europe for a different indication.

The Phase 2, multi-centre, randomised, double-masked, parallel group study will assess the efficacy and safety of KHK4951.

The clinical trial will enrol 150 DME patients across the US, Australia, Japan, and South Korea.

Its primary outcome measure is a decrease of 15 or more letters from baseline in Best Corrected Visual Acuity (BCVA) as calculated by the early treatment diabetic retinopathy study (ETDRS) visual acuity chart.

Kyowa Kirin senior managing executive officer and chief medical officer Takeyoshi Yamashita said: “Tivozanib eye drops have the potential to provide a novel non-invasive treatment option for patients with DME.

“The current standard of care is intravitreal injection drugs, which causes various burdens for patients, caregivers and doctors.

“We believe KHK4951 has the potential to address patient needs and preferences for a less invasive mode of administration.”

Additionally, a different Phase 2 trial is being started to assess KHK4951 in individuals with nAMD. Patients are currently being recruited for this mid-stage trial.

Last month, Kyowa Kirin completed the $477.6m acquisition of rare disease-focused gene therapy firm Orchard Therapeutics.