Kyowa Kirin enrolls first patient in phase 2 trial of drops for treatment of diabetic macular edema


The trial will evaluate tivozanib eye drops (KHK4951), a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI), in patients in with DME.

Woman doctor applying eye drops to a patient (Image credit: AdobeStock/rh2010)

(Image credit: AdobeStock/rh2010)

Kyowa Kirin has announced the enrollment of the first patient in its phase 2 trial evaluating tivozanib eye drops (KHK4951) in patients with diabetic macular edema (DME).

Tivozanib, which is the active ingredient in 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.1

According to the company, KHK4951 is a “novel nano-crystalized tivozanib eye drop” designed to deliver the drug to the posterior ocular tissues.1

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

The drug is also being evaluated as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and a phase 2 study is currently recruiting.

The phase 2 study will be recruiting 150 patients with DME across the US, Japan, Australia, and South Korea, according to the company, with a primary outcome measure of “reduction of 15 or more letters from baseline in BCVA (Best Corrected Visual Acuity) as measured by the ETDRS visual acuity chart.”

  1. Kyowa Kirin Announces First Patient Enrolled in the Phase 2 Clinical Trial Evaluating Tivozanib Eye Drops in Patients with Diabetic Macular Edema. Press release; February 6, 2024. Accessed February 8, 2024.
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