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Ivantis Announces 3 Year Results of Australian SPECTRUM Registry for Hydrus Microstent

22:00 EST 7 Nov 2019 | PR Newswire

Largest Set of MIGS Data Ever Produced in Australia Includes Over 900 Eyes with 200+ Stand-Alone Glaucoma Procedures

IRVINE, California, Nov. 8, 2019 /PRNewswire/ -- Ivantis today announced long term results of the Australian cohort of the Global SPECTRUM registry. SPECTRUM is a post market patient registry for the Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device to treat patients with open-angle glaucoma in conjunction with cataract surgery or as a stand-alone procedure outside the United States.

The SPECTRUM Registry was conceived in collaboration with leading Australian glaucoma specialists and comprehensive ophthalmologists. The study received initial ethics approval from the Royal Australia New Zealand College of Ophthalmologists (RANZCO) in 2014. Over 900 patients were recruited from 12 top eye surgery centers across Australia and New Zealand, making this the largest body of MIGS data produced from the region to date. SPECTRUM Australia includes a broad range of disease ranging from very mild glaucoma patients undergoing cataract surgery to stand-alone patients with moderate disease unresponsive to medical therapy to advanced cases requiring standalone Hydrus following unsuccessful conventional glaucoma surgery. Follow-up at 3 years was completed in 70% of eligible subjects.

The data will be presented at the Royal Australian & New Zealand College of Ophthalmologists Annual Scientific Congress in Sydney, Australia on November 9, 2019 by Ashish Agar, MBBS, PhD. A glaucoma specialist from the Prince of Wales Hospital in Sydney, Dr. Agar was one of the first surgeons to use the Hydrus Microstent in Australia & New Zealand.  

Key findings at 3 years include:

  • In patients undergoing combined cataract surgery and Hydrus placement, mean IOP dropped over 20% with concurrent elimination of a full medication
  • In patients undergoing standalone Hydrus placement, mean IOP dropped roughly 30%, with concurrent elimination of a full medication (this group had higher baseline pressures due to more severe disease)
  • Patients in the registry reached average intraocular pressures of 15 mmHg or less in both the combination cataract surgery and standalone treatment groups
  • The results in both treatment groups were consistent at 1, 2, and 3 years, making the SPECTRUM Australia series the largest MIGS series followed for 3 years

According to Dr. Agar, a contributor to SPECTRUM Australia, "It's an honor to see the effort put into the SPECTRUM registry follow up come to fruition with the release of this comprehensive and important data set dedicated to Australian and New Zealand glaucoma patients.  I have now used the Hydrus for over 5 years, and a few things about this data set stand out.  First, the device effect is remarkably consistent over time, which is critical when remembering that glaucoma is a long-term disease. Second, it is clear from the results of the combination and standalone groups that the device significantly lowers IOP with or without cataract surgery. This is especially important as standalone data has been crucial in our advocacy for this technology to be accessible to all patients, not just those with co-existing cataract. Finally, not only does this data mirror the robust published randomized trial results we have seen with Hydrus, but there is great consistency across all 12 sites in SPECTRUM, and that is reassuring on many levels.  I wish to congratulate Ivantis, and my fellow investigators for the commitment to this important initiative for our patients."

Dr. Brendan Cronin, Director of Education at the Queensland Eye Institute, and leading contributor to the registry, commented, "The Hydrus has become an invaluable addition to my practice since I added it 5 years ago. As a general ophthalmologist, typically treating milder disease in conjunction with cataract surgery, my goal is to safely eliminate medications for my patients.  I find the Hydrus excels in achieving this.  Our patients typically reflect the mildest end of the disease spectrum, and we found that over 80% of our patients remained medication free to 2 years and over 70% remain so at 3 years.  My referring optometrists have noticed a profound impact from Hydrus with their patients, and it's a privilege to now see this experience become a part of the broader 3 year SPECTRUM Australia presentation."

Ivantis was founded in 2007, and the Hydrus has been developed in part through investment support from GBS Ventures of Melbourne.

Dave Van Meter, President and CEO of Ivantis, remarked, "Ivantis has been built with a goal to provide the most robust data sets in the MIGS space to allow surgeons to make the most informed decisions for their patients.  We are thrilled to have endeavored on this major undertaking in partnership with key ophthalmology leadership in Australia and New Zealand.  We now look forward to ongoing commercialization in the region on the back of this important new data set dedicated to Australian and New Zealand patients and the surgeons who treat them."

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 Tri-Modal™ 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.

About the SPECTRUM Global Registry
SPECTRUM is the world's largest single-device registry in ophthalmology, and completed enrollment in November 2019.  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.

The entire body of SPECTRUM data will be presented in 2021, and certain early subsets will be shared throughout 2020 at various medical conferences.

INDICATIONS FOR USE:
The Hydrus Microstent is indicated for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG) as a standalone treatment or in conjunction with cataract surgery.

About Ivantis
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.

Hydrus® is a registered trademark of Ivantis, Inc. All rights reserved. 2019.

www.IvantisInc.com

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