04.23.19

Ivantis Announces Publication of Comparative MIGS Clinical Trial Results

Source: Ivantis

Ivantis, developer of the Hydrus Microstent, announced that the 12-month results of the COMPARE study for minimally invasive glaucoma surgery (MIGS) were accepted into the journal Ophthalmology, according to a company news release.

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:

  • 47 percent of eyes in the Hydrus Microstent group were medication free, compared to 24 percent of eyes in the two iStent group.
  • Medication use was reduced on average by 1.6 medications, or 61 percent, in the Hydrus Microstent group, compared to a reduction of one medication, or 37 percent, in the two iStent group.
  • 73 percent of patients receiving the Hydrus Microstent achieved at least a 20 percent reduction in IOP while on fewer medications, compared to 47 percent of the two iStent eyes.

“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,” 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, said in a company news release. “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,” Dave Van Meter, President and CEO of Ivantis, said in the news release. “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.

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:¬†

  1. The Hydrus Microstent creates a bypass through the trabecular meshwork, allowing outflow of aqueous humor.
  2. It then dilates and scaffolds Schlemm’s canal to augment outflow.
  3. 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.

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