Ivantis today released one-year results from the study of its Hydrus Microstent comparing it to Glaukos‘ (NYSE:GKOS) iStent trabecular micro-bypass stents, touting the Hydrus’ ability to reduce reliance on medication and intraocular pressure.
Results from the trial were presented at the American Society of Cataract and Refractive Surgery annual meeting in Washington D.C. by Dr. David Chang of the University of California, San Francisco, Irvine, Calif.-based Ivantis said.
The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large opening through the trabecular meshwork and dilating and scaffolding the conventional pathway through which fluid exits the eye.
“This is a necessary, novel and well-run study conducted by a group of experts in the field of MIGS. Not only is it the first to compare two different canal-based technologies in a Level One evidence clinical trial, but it is the first prospective, randomized data reported where we can evaluate MIGS devices in a standalone glaucoma setting. These MIGS approaches, when combined with cataract surgery, have been previously reported to be safe and effective. This study looks at the viability of MIGS in patients who don’t need or may have already had cataract surgery, so it’s a vital addition to our growing body of evidence supporting MIGS,” Compare trial medical monitor Dr. Iqbal Ahmed said in a prepared release.
Ivantis said the 152-patient trial was the first to compare two minimally invasive glaucoma surgery device for treating open-angle glaucoma in a standalone procedure. The study aimed to compare safety and effectiveness of both devices in lowering IOP and reducing eye-drop medication.
Results at one year showed that 47% of eyes treated with the Hydrus Microstent were medication free, compared to 24% of eyes treated with the iStent device. Medication use was reduced by 61% for Hydrus patients, the company reported, with a 37% reduction for patients treated with the iStent.
A total of 73% of patients who received the Hydrus stent achieved a 20% reduction in IoP while on fewer medications, compared to 47% in the iStent cohort.
“To date, we have had no comparative data from prospective randomized studies evaluating two different MIGS devices. Furthermore, we have had very few, if any, level one evidence clinical trials assessing MIGS in a standalone glaucoma surgery setting. Compare is not only a multi-center study but also a ‘real world’ MIGS assessment, given the wide range of glaucoma severity and the fact that 12 experienced, expert surgeons from eight countries participated. It is notable that participation criteria required that all surgeons were past the learning curve for each MIGS platform. The Compare data will be helpful in evaluating canal-based MIGS in a wide range of clinic situations, and it will demonstrate the benefit of dilating Schlemm’s canal and gaining access to multiple outflow collector channels. I look forward to the peer-reviewed publication of these results and further analysis with longer follow-up,” Ivantis global medical monitor Dr. Thomas Samuelson said in prepared remarks.
“These results illustrate the clinical advantages of the Hydrus and its unique, proprietary tri-modal mechanism of action. Combined with best-in-class data in the cataract surgery setting, this adds to what we believe is the broadest and highest-level evidence seen to date for a MIGS device. 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 results. We are grateful to the investigators for their support and contributions,” prez & CEO Dave Van Meter said in a press release.
Last April, Ivantis said it won approval from the FDA to initiate a 2nd investigational device exemption trial of its Hydrus microstent, testing the device in patients with advanced glaucoma who are undergoing stand-alone glaucoma surgery without combined cataract surgery.