Largest Single-Device Ophthalmic Registry Includes Nearly 3,000 Eyes with 700+ Stand-Alone Glaucoma Procedures
IRVINE, Calif., Oct. 10, 2019 /PRNewswire/ — SPECTRUM, the world’s largest single-device registry in ophthalmology, has completed enrollment. The announcement was made today by Ivantis Inc., a company dedicated to developing new and innovative solutions for glaucoma. SPECTRUM is a patient registry for the Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device to treat patients with mild to moderate primary open-angle glaucoma (POAG) in conjunction with cataract surgery or as a stand-alone procedure outside the United States.
The SPECTRUM Registry, initiated in 2013 in markets outside the U.S., covers the broadest range of glaucoma ever studied in a single body of data for a MIGS device and includes cases from 50 centers in 19 countries. It comprises nearly 3,000 eyes and to date has over 70% follow-up. Of the procedures captured in the SPECTRUM Registry, over 700 were in stand-alone glaucoma cases — the largest reported series of stand-alone glaucoma cases in MIGS. In a cohort of nearly 250 eyes followed for three years, intraocular pressure was reduced by 29% with a commensurate reduction of one medication compared to preoperative levels.
The entire body of SPECTRUM data will be presented in 2021, and certain early subsets will be shared this weekend at the American Academy of Ophthalmology, as well as throughout 2020 at various medical conferences.
“I congratulate Ivantis and the participants from the 50 centers around the world for the substantial commitment and effort put into generating this unprecedented volume of important new MIGS information,” said Richard A. Lewis, MD, of Sacramento Eye Consultants, member of Ivantis’ Advisory Board, and past president of the American Glaucoma Society and the American Society of Cataract and Refractive Surgeons. “The SPECTRUM Registry will offer us a glimpse into what the future of MIGS may hold in the United States.”
Dr. Lewis noted that SPECTRUM Registry surgeons were able to work within a much broader indication than is currently approved in the United States. “The early data suggest this device has utility and range that provides true patient benefit in a wide range of glaucoma, and we will work diligently over the coming years to publish and present new and important data subsets that we hope will illuminate the MIGS field.”
According to Gus Gazzard, MBBChir MA MD FRCOphth, director of the Glaucoma Service at the prestigious Moorfields Eye Hospital, professor in ophthalmology, glaucoma studies at UCL London, a consultant ophthalmic surgeon (glaucoma and cataract) and chief investigator of the Laser in Glaucoma and Ocular Hypertension Trial (LiGHT), and the leading European contributor with over 200 cases in the registry, “I have been using the Hydrus stent for nearly five years across a vast array of patients, ranging from my patients with mild disease undergoing cataract surgery to those who have highly advanced glaucoma. I find the Hydrus to be uniquely versatile in terms of providing the best combination of safety and efficacy for a remarkably broad range patients. I have been particularly impressed by the sustained efficacy the device provides in a very safe manner, even in absence of cataract surgery, and I am excited to see what a comprehensive review of this extraordinary data set will provide in terms of our arsenal of MIGS knowledge.”
“We are grateful to the SPECTRUM centers for their commitment to evidence-based research in glaucoma,” said Dave Van Meter, CEO of Ivantis. “By adding the SPECTRUM outcomes to our HORIZON pivotal trial, for which we recently presented three-year results, Ivantis now has the largest randomized controlled trial and the largest registry in the MIGS space. The SPECTRUM Registry should prove to be an insightful complement to our considerable array of level-one randomized controlled trial publications. Over the last year since FDA approval, we have been extremely pleased by the strong reception of our Hydrus Microstent by the clinical community, and our long-term clinical data has been an important driver for this adoption.”
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 into the trabecular meshwork and the canal during MIGS, the aqueous drainage device restores the flow of fluid in the eye using a trimodal mechanism of action. First, it creates a bypass through the trabecular meshwork, allowing outflow of aqueous humor. It also dilates and scaffolds Schlemm’s canal to augment outflow. Finally, with a length that spans 90 degrees of the canal, it provides consistent access to the fluid collector channels in the eye.
The Hydrus® Microstent is one of the most rigorously researched and thoroughly studied of all MIGS devices, with more than 4,000 cases treated globally in patients with a wide range of disease severities in randomized trials or registries.
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 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 IOP. 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 intraocular lens 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 of the Hydrus® Microstent included partial or complete device obstruction (7.3%); worsening in visual field mean deviation by > 2.5 dB compared with preoperative (4.3% vs. 5.3% for cataract surgery alone); device malposition (1.4%); and best corrected visual acuity loss of ≥ 2 ETDRS lines ≥ 3 months (1.4% vs. 1.6% 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 conditions. 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, California.
Ivantis® and Hydrus® are registered trademarks of Ivantis Inc. All rights reserved. 2019.