ABK Biomedical has finished enrolling patients in a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) study evaluating its Eye90 microspheres for the treatment of unresectable hepatocellular carcinoma (HCC).
Eye90 microspheres are a yttrium-90 radioembolization device designed to treat unresectable liver tumors. Eye90 has received FDA breakthrough device designation and is capable of enhanced visualization and personalized dosimetry based on individual patient and tumor anatomy, ABK Biomedical said.
The ROUTE90 study is an international, prospective, open-label, multicenter phase III trial enrolling 120 patients across multiple sites.
The co-primary endpoints of the study are overall response rate and duration of response, with enrolled patients to be followed for one year post-treatment, according to the company.
