Hydrus microstent wins FDA approval

The FDA has approved the use of the Hydrus microstent in conjunction with cataract surgery to reduce IOP in patients with mild to moderate primary open-angle glaucoma.

Designed by Ivantis, this next-generation MIGS device relieves high IOP by reestablishing ocular fluid flow through the Schlemm’s canal. According to David Chang, MD, clinical professor of ophthalmology at UC San Francisco, the device scaffolds approximately 90 degrees of the patient's natural canal outflow pathway, and surgeons can easily confirm its correct anatomic placement in the canal.

The FDA’s approval was based on the 24-month results from the HORIZON trial, the largest MIGS study to date. The study included 556 mild to moderate glaucoma patients randomly assigned to undergo cataract surgery with or without the microstent. More than 77% of patients with the implant exhibited a significant decline in unmedicated IOP, compared with 58% of the control group. On average, the device reduced IOP by 7.5 mmHg, approximately 2.3 mmHg more than the cataract surgery-only group.

Common adverse events noted included device obstruction, worsening of visual field mean deviation by 2 dB or more, and BCVA loss of more than 2 ETDRS lines.

“The overall body of clinical data supporting Hydrus is very encouraging in terms of both safety and two-year efficacy and sets a new bar for the treatment of mild to moderate glaucoma in cataract patients,” said Dr. Chang, who served as an investigator on the trial. “It also appears to be very effective at eliminating medications, compared to cataract surgery alone. I look forward to offering Hydrus to my patients."

The Hydrus microstent is already widely used in other countries; Ivantis estimates that more than 4,000 procedures have been performed globally for a range of disease severities. The California-based company hopes to launch the product later this year.