Study Investigates Eye90 Microspheres for Treatment of Liver Tumors
ABK Biomedical has announced the approval and initiation of a first-in-human study with Eye90 microspheres, a Y90 radioembolization device, in collaboration with Auckland Hospital Research Unit in New Zealand.
The prospective, single-center, open-label study will evaluate the safety and effectiveness of Eye90 microspheres in patients with unresectable hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC). Patients will receive a single Eye90 microspheres radioembolization treatment with follow-up visits for one year to assess safety, effectiveness, and quality of life measures.
Eye90 microspheres are radiopaque glass microspheres that are visible on X-ray and CT imaging and contain the Yttrium 90 (Y90) radiotherapeutic element. Y90 radioembolization, a local brachytherapy, is currently used to treat malignant liver tumors.
“The ABK team has worked tirelessly over the past three years to bring our technology to patients suffering from HCC and mCRC liver tumors,” said Mike Mangano, President and CEO of ABK Biomedical. “We are pleased to partner with Dr. Andrew Holden and the team at Auckland Hospital to be the first to treat patients in New Zealand with Eye90 microspheres. Our Eye90 microspheres device is designed with key advancements over the currently marketed Y90 radioembolization therapies with the goal of improving the physician experience and patient outcomes. Eye90 microspheres combine in-procedure, tumor-targeting visualization of radiopaque microspheres, and an advanced delivery system allowing physician control of administration, with the proven clinical benefits of Y90 radioembolization therapy.”
“We are enthusiastic to partner with ABK Biomedical to conduct this important First-in-Human clinical study. We are eager to evaluate the advancements of the Eye90 device and report on the initial safety and efficacy for the treatment of HCC and mCRC liver tumors,” said Andrew Holden, MD, MBChB, FRANZCR, EBIR, ONZM, study principal investigator.