ABK Biomedical Gains IDE Approval for Pivotal Study of Eye90 Microspheres to Treat Hepatocellular Carcinoma

May 30, 2023—ABK Biomedical, Inc. announced it has received Investigational Device Exemption approval from the FDA to commence a multicenter pivotal clinical study in the United States for the company’s imageable Eye90 microspheres yttrium-90 (Y90) radioembolization therapy. The pivotal Route90 clinical study is designed to evaluate the safety and efficacy of Eye90 microspheres in patients with unresectable hepatocellular carcinoma (HCC).

According to the company, the Route90 study will evaluate HCC tumor response rates and duration of response from Eye90 microspheres treatment as coprimary endpoints. The study also includes endpoints to evaluate safety, the potential benefits of intraprocedural visualization, and the ability to perform posttreatment CT dosimetry with imageable microspheres.

The study’s principal investigator is Andrew Kennedy, MD, Physician in Chief of Radiation Oncology at Sarah Cannon Cancer Institute in Nashville, Tennessee.

“I’m excited to participate and lead the Route90 study,” commented Dr. Kennedy in ABK Biomedical’s press release. “Eye90 microspheres is a significant and meaningful technology advancement to Y90 radioembolization therapy not seen in over almost 2 decades since the current therapies became clinically available.”

Aravind Arepally, MD, who is Chief Medical Officer of ABK Biomedical, added, “We’re motivated to begin this pivotal study and assess the Eye90 microspheres technology in a large well-controlled, well-designed study. We continue to build upon the results of our first-in-[human] Eye90 microspheres study conducted recently in New Zealand. The initial results from this study are highly encouraging with an excellent safety profile and robust tumor response rates.”