Ivantis announced that it 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 Hydrus represents a unique next-generation, canal-based MIGS therapy through what we call our trimodal mechanism of action,” Dave Van Meter, President and CEO, Ivantis, said in an interview with EyewireTV. “We have a large bypass inlet that allows fluid into the canal through the proximal end of the device. The device also dilates and scaffolds the canal, and it does so by spanning 90 degrees of the canal. What this does is it allows the clinicians access to multiple collector channels for lower IOPs.”
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 (treatment) or cataract surgery alone (control). 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 postoperative, compared to 57.8 percent 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.
The secondary effectiveness endpoint was also met, with Hydrus Microstent patients achieving a mean IOP reduction of 7.5 mmHg, a difference of 2.3 mmHg compared to cataract surgery alone. Several epidemiological studies have shown that each point of IOP reduction reduces the risk of progression of glaucoma. The 43 percent improvement for the treatment group over control is also the largest of any MIGS pivotal trial to date. The HORIZON Trial results have been accepted for publication in Ophthalmology (in press, available online June 23, 2018).
“The overall body of clinical data supporting Hydrus is very encouraging in terms of both safety and 2-year efficacy and sets a new bar for the treatment of mild to moderate glaucoma in cataract patients,” David F. Chang, MD, clinical professor of Ophthalmology at the University of California, San Francisco, said in a company news release. “It also appears to be very effective at eliminating medications, compared to cataract surgery alone. I look forward to offering Hydrus to my patients.”
Mr. Van Meter said the company is now proceeding with building its commercial and manufacturing infrastructures and intends to launch the product later this year.
More than 4,000 cases using the Hydrus Microstent have be performed globally, in patients with a wide range of disease severities.