International Multi-center Study Results Comparing Effectiveness of the Hydrus® Microstent to Two Glaukos iStent® Trabecular Micro-Bypass Stents in Standalone Glaucoma Published in Ophthalmology
IRVINE, Calif., April 23, 2019 /PRNewswire/ — Ivantis Inc., developer of the Hydrus® Microstent, announced today that the 12-month results of the COMPARE study for minimally invasive glaucoma surgery (MIGS) were accepted into the journal Ophthalmology.
COMPARE is the first prospective, multicenter, randomized trial comparing two MIGS devices, the Hydrus Microstent versus two Glaukos iStent® Trabecular Micro-bypass stents, for the treatment of open-angle glaucoma in a standalone procedure. The trial included 152 patients with mild to late-moderate stage disease and no previous glaucoma surgery. The study was conducted at 12 centers in 9 countries outside of the US. It was designed to compare the safety and effectiveness of both devices for lowering IOP and reducing eye-drop medication. The comparative trial involved experienced MIGS surgeons who were beyond their surgical learning curves for both devices. The trial was designed to be a pure head-to-head comparison of devices without the confounding effect of cataract surgery, which has also been shown to lower IOP.
Iqbal “Ike” Ahmed, MD, distinguished Binkhorst medal recipient and lecturer at ASCRS on the topic of MIGS, and a Scientific Advisory Board member for both technologies studied in COMPARE, served as medical monitor for the trial. Results from the study were initially presented by David Chang, MD, clinical professor of Ophthalmology at the University of California, San Francisco, and past President of the American Society of Cataract and Refractive Surgery (ASCRS), at the ASCRS Annual Meeting in April 2018.
The 12-month results showed the following:
According to Randy Craven, MD, Chief, Wilmer Eye Institute at Johns Hopkins University in Bethesda, MD, and an investigator in the trial while serving as Chief of Glaucoma at the prestigious King Khaled Eye Specialist Hospital (KKESH) in Saudi Arabia, “The COMPARE Trial is a necessary and highly anticipated study. It is the first prospective, multicenter, randomized ‘head-to-head’ trial in the MIGS category, and involved surgeons past their learning curves with both devices treating patients with a broad array of disease. Importantly, this study isolates the device effect from the cataract surgery effect – which on its own is known to lower IOP. Canal-based surgery is the prevalent modality within the MIGS category, and, as a glaucoma specialist, it is useful for my peers and I to be able to see the mechanistic effect alone of these devices. I am encouraged by these results, and what it may mean for future indications for use of these technologies as standalone procedures. On behalf of the investigators, we are pleased to see the acceptance for publication in Ophthalmology.”
“We are proud and gratified to have the COMPARE 12 month results published in Ophthalmology,” said Dave Van Meter, President and CEO of Ivantis. “This publication illustrates the clinical advantages of the Hydrus and its unique, proprietary Tri-Modal mechanism of action, while also underscoring the high caliber of evidence-based medicine the community has come to expect from Ivantis. Of the over 100 peer reviewed publications in the MIGS space, only 6 have met the rigor required for acceptance to Ophthalmology, and Ivantis studies comprise 3 of those, the most of any company. We are proud to sponsor clinical trials of this caliber, and we congratulate the authors and investigators on this important publication.”
The COMPARE 2 Year results were recently presented in March 2019 at the annual meeting of the American Glaucoma Society, and will be presented again next month at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Annual meeting.
About the Hydrus Microstent
Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm’s canal, the eye’s natural outflow pathway. When placed in the canal during minimally invasive microsurgery, the device restores the flow of fluid in the eye, using a Tri-Modal mechanism of action:
The Hydrus Microstent is one of the most rigorously researched and thoroughly studied MIGS devices, with more than 4,000 cases treated globally in controlled clinical studies and registries, in patients with a wide range of disease severities.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE:
The Hydrus Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).
The Hydrus Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; and (2) In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle.
Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard.
The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with preexisting pseudophakia, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes that have undergone argon laser trabeculoplasty (ALT), eyes with unmedicated IOP < 22 mmHg or > 34 mmHg, eyes with medicated IOP > 31 mmHg, eyes requiring > 4 ocular hypotensive medications prior to surgery, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment and when implantation is without concomitant cataract surgery with IOL implantation. The safety and effectiveness of the use of more than a single Hydrus Microstent has not been established.
Common postoperative adverse events reported in the randomized pivotal trial included partial or complete device obstruction (7.3 percent); worsening in visual field MD by > 2.5 dB compared with preoperative (4.3 percent vs. 5.3 percent for cataract surgery alone); device malposition (1.4 percent); and BCVA loss of ≥ 2 ETDRS lines ≥ three months (1.4 percent vs. 1.6 percent for cataract surgery alone). For additional adverse event information, please refer to the Instructions for Use.
The Hydrus Microstent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified condition, please see the Instructions for Use and Patient Information Card for details.
Please refer to the Instructions for Use for complete product information.
Ivantis, Inc. is a privately held company established in 2007 to design, develop and commercialize new technologies to treat eye disease. Investors include New Enterprise Associates, Delphi Ventures, Foresite Capital, RA Capital Management, Ascension Ventures, EDBI, GBS Ventures, MemorialCare Innovation Fund, Merieux Development, and Vertex Healthcare. The company is headquartered in Irvine, Calif.
Hydrus Microstent is not currently approved for sale in the United States for standalone use in primary open angle glaucoma.