Kyowa Kirin to Present Pre-Clinical Data at ARVO 2024

Kyowa Kirin Co., Ltd. recently shared data from a pre-clinical study on the pharmacokinetics and efficacy of tivozanib eye drops. This information will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Seattle. The study focuses on the distribution of tivozanib, a nano-crystallized eye drop formulation, in ocular tissues after administration. The goal is to evaluate its potential as a treatment for neovascular age-related macular degeneration (nAMD).

nAMD is a severe form of age-related macular degeneration, characterized by rapid central vision loss due to abnormal blood vessel growth and leakage in the macula. While nAMD makes up about 10% of all AMD cases, it is responsible for nearly 90% of AMD-related vision loss. As life expectancy increases, the incidence of AMD is expected to rise, posing significant challenges for patients and healthcare systems.

The data from Kyowa Kirin revealed that nano-crystallized tivozanib (nTivo) eye drops showed a significant improvement in drug delivery efficiency to the retina and choroid in pigmented rabbits when compared to microcrystal formulations. Repeat administration of nTivo eye drops resulted in higher drug exposure in the retina and choroid than a single administration. Additionally, the elimination half-life of tivozanib was longer in the retina and choroid compared to the serum. These findings suggest that the higher exposure and longer half-life in pigmented rabbits could be attributed to the binding properties of melanin and the nano-crystallized formulation.

Furthermore, in a laser-induced choroidal neovascularization model in monkeys, nTivo eye drops reduced the lesion area and showed increased drug concentration in the choroid and retina with higher dosing frequency. This suggests that nTivo eye drops could be a promising therapeutic option for treating posterior eye diseases.

Kyowa Kirin has also completed a phase 1 clinical trial in Japanese patients with nAMD. Judit Baffi, the lead Clinical Science Ophthalmologist at Kyowa Kirin, expressed excitement about the preclinical data and the potential of nTivo eye drops to ease the treatment burden for patients and healthcare teams.

Apart from the pre-clinical study, Kyowa Kirin is conducting separate phase 2 clinical trials for tivozanib eye drops (KHK4951) to assess their safety and efficacy in patients with nAMD and diabetic macular edema (DME). These trials are multi-center, randomized, double-masked, and parallel group studies.

Tivozanib is a tyrosine kinase inhibitor (TKI) that targets vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. The investigational product KHK4951 is a novel nano-crystallized tivozanib eye drop formulated to deliver the active ingredient to the posterior ocular tissues. It holds potential as a treatment for nAMD and DME. An oral formulation of tivozanib, marketed as FOTIVDA®, is available for different indications by AVEO Pharmaceuticals in the US and EUSA Pharma in Europe.

Kyowa Kirin, a global specialty pharmaceutical company based in Japan, has been investing in drug discovery and biotechnology innovation for over 70 years. The company is dedicated to developing novel treatments that offer significant value to patients, particularly in areas with high unmet medical needs such as bone/mineral disorders, intractable hematological diseases, hemato-oncology, and rare diseases.