Ivantis said today it won FDA approval for its Hydrus microstent designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.
The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large opening through the trabecular meshwork and dilating and scaffolding the conventional pathway through which fluid exits the eye.
Approval came based on results from the Horizon trial, which the Irvine, Calif.-based company touted as the largest minimally invasive glaucoma surgery study conducted to date. The 556-patient study examined patients with mild to moderate glaucoma undergoing cataract surgery, randomized between treatment with the Hydrus or cataract surgery alone.
Results indicated that 77.2% of patients in the Hydrus group saw a greater than 20% reduction in unmedicated intraocular pressure at 24 months post-op, significantly higher than the 57.8% reduction in the control group. Data also indicated a a mean IOP reduction of 7.5 mmHg, a difference of 2.3 mmHg compared to the control group.
“We are pleased by the FDA’s approval of our Hydrus Microstent. Although the device has been used in over 4,000 procedures internationally, many of which are now well past five years, the Hydrus Microstent represents a novel device platform to FDA, and this approval occurred within our projected timeline. We are now proceeding with building our commercial and manufacturing infrastructures and intend to launch the product later this year. We thank the FDA for their timely review, and we look forward to Hydrus Microstent becoming an important part of the cataract surgeons’ and glaucoma specialists’ surgical armamentarium,” Ivantis CEO Dave Van Meter said in a press release.
In April, Ivantis released one-year results from the study of its Hydrus Microstent comparing it to Glaukos‘ (NYSE:GKOS) iStent trabecular micro-bypass stents, touting the Hydrus’ ability to reduce reliance on medication and intraocular pressure.