Japan’s Kyowa Kirin has commenced a Phase II clinical trial of tivozanib eye drops (KHK4951) for diabetic macular oedema (DME), with the first subject now enrolled.

The trial aims to assess the safety and efficacy of KHK4951 in patients with DME across multiple countries, including the US, Japan, Australia, and South Korea.

This multicentre, double-masked, randomised, parallel group trial is set to recruit 150 DME patients.

A decline of 15 or more letters from baseline in Best Corrected Visual Acuity (BCVA), as determined by the ETDRS visual acuity chart, will be the trial’s primary goal.

Tivozanib, the active ingredient in KHK4951, is a tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3.

The nano-crystalised formulation of tivozanib eye drops is claimed to efficiently deliver it to the posterior ocular tissues.

KHK4951 is under development as a potential therapy option for neovascular (wet) age-related macular degeneration (nAMD) and DME.

An oral version of tivozanib is already on the market in the US, under the brand name FOTIVDA by AVEO Oncology, and in Europe by EUSA Pharma for different indications.

A separate Phase II study for KHK4951 in nAMD patients is also currently underway.

This trial is also in the subject recruitment stage.

Earlier this year, Kyowa Kirin completed the acquisition of Orchard Therapeutics, with the integrated business now focusing on addressing requirements in genetic diseases and other serious conditions, where treatment options are currently limited or non-existent.

In September 2023, Kyowa Kirin disclosed that the Phase III KOUNO-TORI trial of KW-3357 for preeclampsia in Japan failed to meet its primary endpoint.

The company, along with MEI Pharma, reported topline data from the Phase II MIRAGE trial of zandelisib in indolent B-cell non-Hodgkin’s lymphoma patients in November 2022.

Kyowa Kirin board director, chief medical officer and senior managing executive 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.”