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Ivantis Announces 24-Month Results of Landmark Prospective, Randomized Comparative MIGS Clinical Trial
SAN FRANCISCO, and IRVINE, Calif., March 14, 2019 /PRNewswire/ -- Ivantis Inc., developer of the novel Hydrus® Microstent, a device designed to lower eye pressure for open-angle glaucoma patients, announced today the 24-month results of the COMPARE study for minimally invasive glaucoma surgery (MIGS). Results from the study will be presented by Thomas Samuelson, MD, President of the American Society of Cataract and Refractive Surgeons (ASCRS), during the American Glaucoma Society (AGS) annual meeting in San Francisco, CA on March 14th at 12:53 EDT.
COMPARE is the first prospective, multi-center, randomized trial comparing two MIGS devices, the Hydrus Microstent versus two large-diameter iStent® Trabecular Micro-Bypass Stents (Glaukos Corp.), for the treatment of open-angle glaucoma in a standalone procedure. The trial included 152 patients with mild to late-moderate stage disease and was conducted at 12 centers in nine countries outside of the US. It was designed to compare the safety and effectiveness of both devices in lowering intraocular pressure (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 on the topic of MIGS, and a Scientific Advisory Board member for both technologies studied in COMPARE, served as medical monitor for the trial.
The 24-month results showed the following:
- Two times the number of patients in the Hydrus Microstent group were medication free compared to the two-iStent group (38.0 percent versus 18.7 percent).
- Medication use was reduced on average by 1.3 medications, or 52 percent, in the Hydrus Microstent group, compared to a reduction of 0.8, or 29 percent, in the two-iStent group.
- None of the eyes in the Hydrus Microstent group required a reoperation to control glaucoma, compared to 9 percent in the two-iStent group.
- 63 percent of patients receiving the Hydrus Microstent achieved at least a 20 percent reduction in IOP while on fewer medications, compared to 40 percent of the two-iStent patients.
- Both groups showed general stability in terms of medication reduction and IOP relative to the previously presented 12 month results.
According to Dr. Douglas J. Rhee, Professor of Ophthalmology and Chair of the Department of Ophthalmology and Visual Sciences at University Hospitals / Case Western Reserve University School of Medicine, and Chair of the Glaucoma Clinical Committee for ASCRS, and a participant in the trial, "The results from the COMPARE Trial correlate closely with what we have previously observed in our laboratory and others on the various trabecular bypass devices. We showed that there is clearly an advantage to the Hydrus implant, which both bypasses and scaffolds the canal, allowing access to a greater portion of the natural collector channel system, as opposed to either single or dual micro-bypass only. I congratulate all the other investigators and Ivantis for conducting such a rigorous study."
Dr. Samuelson commented, "The clinical community will be pleased to see 24-month results for the first controlled 'head-to-head' trial in the MIGS space, and there are some important and practical takeaways here. First, although this is a controlled trial, it is quite 'real world' in the sense that the surgeons were trained experts in both technologies and the population included a wide range of disease severity. Second, we know cataract surgery alone is effective at reducing IOP, and, while the predominant application of MIGS today is in conjunction with cataract surgery, the results of this trial allows us great optimism for the role of these technologies as 'standalone' procedures. Third, while not a prespecified endpoint, a critical finding was a statistically significant difference in secondary surgical interventions at 2 years in favor of Hydrus. Ultimately, the goal of all MIGS – and all glaucoma therapy in general - is to stop progression of disease. While both devices had overall benefit for the patient, on this metric, Hydrus as a stand-alone procedure was excellent. This data set is an important contribution to our overall understanding of the role of MIGS devices in our armamentarium."
"We are extremely pleased with these 2 year results," said Dave Van Meter, President and CEO of Ivantis. "These results illustrate the clinical advantages of the Hydrus and its unique, proprietary Tri-Modal™ mechanism of action relative to focal trabecular bypass. Clearly, scaffolding the canal has unique benefit. Of the over 100 peer reviewed publications in the MIGS space, there are only a small handful of prospective, multicenter randomized trials, and Ivantis has conducted nearly half of those, which is a significant achievement for a company that is the most recent to commercialize in the MIGS category. We are proud to sponsor clinical trials of this caliber, enabling the COMPARE investigators to advance our understanding of the Hydrus Microstent and the MIGS field overall, and we look forward to the publication of these important 2 year results. We are grateful to the investigators for their support and contributions."
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 creates a bypass through the trabecular meshwork, allowing outflow of aqueous humor.
- It then dilates and scaffolds Schlemm's canal to augment outflow.
- Its length spans 90 degrees of the canal to provide consistent access to the fluid collector channels in the eye.
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.
Ivantis® and Hydrus® are registered trademarks of Ivantis, Inc. All rights reserved 2019.
iStent® and Glaukos® are registered trademarks of Glaukos Corporation.
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SOURCE Ivantis, Inc.