■ Ivantis has received FDA approval for the Hydrus Microstent, a microinvasive glaucoma surgery (MIGS) device used to treat patients with mild-to-moderate primary open-angle glaucoma in conjunction with cataract surgery.
The FDA approval is based on the landmark HORIZON trial, the largest MIGS study ever conducted. The study included 556 mild-to-moderate glaucoma patients undergoing cataract surgery, randomized to either receive cataract surgery plus the Hydrus Microstent or cataract surgery alone. More than three-quarters (77.2%) of patients in the Hydrus Microstent group achieved a statistically significant decrease (≥20 percent reduction in unmedicated IOP) at 24 months postoperatively, compared to 57.8% in the cataract surgery alone group, meeting the primary effectiveness endpoint. This represents the largest improvement over control reported in any MIGS pivotal trial to date.
According to David F. Chang, MD, clinical professor of Ophthalmology at the University of California, San Francisco, “Ophthalmologists in the US will certainly welcome the approval of a next-generation canal-based MIGS device. The Hydrus Microstent scaffolds approximately 90 degrees of the patient’s natural canal outflow pathway. Correct anatomic placement into the canal will also be easier for surgeons to confirm. The overall body of clinical data supporting Hydrus is very encouraging in terms of both safety and 2-year efficacy and also appears to be very effective at eliminating medications, compared to cataract surgery alone.”