Phase 2 Trial Begins for Tivozanib Eye Drops in Diabetic Macular Edema

Kyowa Kirin Co., Ltd. has initiated a Phase 2 clinical trial for KHK4951, a nano-crystalized formulation of tivozanib eye drops, which are being evaluated for their effectiveness in treating diabetic macular edema (DME). The trial, involving multiple centers and a double-masked, randomized design, will include 150 participants from the US, Japan, Australia, and South Korea. The primary goal is to measure a significant improvement in Best Corrected Visual Acuity (BCVA) using the ETDRS chart.
Tivozanib, a tyrosine kinase inhibitor developed by Kyowa Kirin, targets vascular endothelial growth factor receptors and is already available in an oral form as FOTIVDA for a different medical condition, marketed by AVEO Oncology in the US and EUSA Pharma in Europe. The eye drop version, KHK4951, is anticipated to offer a non-invasive alternative to current treatments, which primarily involve intravitreal injections, posing challenges for patients and healthcare providers.
Dr. Takeyoshi Yamashita, a leading executive at Kyowa Kirin, expressed optimism about the potential of KHK4951 to meet patient preferences for less invasive treatments. Additionally, a parallel Phase 2 study for KHK4951 in treating neovascular age-related macular degeneration (nAMD) is underway.
Kyowa Kirin, a global specialty pharmaceutical company with a 70-year history of innovation, is dedicated to developing new medicines that can significantly impact patients' lives. The company is currently focused on advancing antibody, cell, and gene therapies for severe and rare diseases. Their mission is to enhance global health by advancing life sciences and technology, with a commitment to sustainability and improving the quality of life for people worldwide.
Diabetic macular edema is a leading cause of vision loss among diabetic patients and impacts approximately 1.3 million individuals in the US. It is characterized by the swelling of the macula due to fluid accumulation, often resulting from retinal vascular leakage. Current treatments for DME are invasive, typically involving anti-VEGF or corticosteroid injections, or surgical options like laser photocoagulation or vitrectomy.
Kyowa Kirin's dedication to creating value through life science and technology advancements reflects their broader goal of contributing to global health and well-being. The company's efforts are unified by a shared set of values and a vision for a future where their medicines bring about meaningful change.