PR Newswire08.14.18
Ivantis, a company dedicated to developing solutions for glaucoma, announced today that it received Food and Drug Administration (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 (treatment) or cataract surgery alone (control). More than three-quarters (77.2 percent) of patients in the Hydrus Microstent group achieved a statistically significant decrease (≥ 20 percent reduction in unmedicated intraocular pressure) 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 intraocular pressure (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, the leading journal in the field (in press, available online June 23, 2018).
According to David F. Chang, M.D., clinical professor of Ophthalmology at the University of California, San Francisco, "Ophthalmologists in the U.S. 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 two-year efficacy and sets a new bar for the treatment of mild to moderate glaucoma in cataract patients. It also appears to be very effective at eliminating medications, compared to cataract surgery alone. I look forward to offering Hydrus to my patients."
"We are pleased by the FDA's approval of our Hydrus Microstent," said Dave Van Meter, president and CEO of Ivantis. "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."
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 percent) of patients in the Hydrus Microstent group achieved a statistically significant decrease (≥ 20 percent reduction in unmedicated intraocular pressure) 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 intraocular pressure (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, the leading journal in the field (in press, available online June 23, 2018).
According to David F. Chang, M.D., clinical professor of Ophthalmology at the University of California, San Francisco, "Ophthalmologists in the U.S. 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 two-year efficacy and sets a new bar for the treatment of mild to moderate glaucoma in cataract patients. It also appears to be very effective at eliminating medications, compared to cataract surgery alone. I look forward to offering Hydrus to my patients."
"We are pleased by the FDA's approval of our Hydrus Microstent," said Dave Van Meter, president and CEO of Ivantis. "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."
