Ivantis Completes Enrollment in Pivotal Hydrus IV Glaucoma Study

Ivantis Inc. has completed enrollment in its Hydrus IV pivotal trial, which the company claims is the largest randomized minimally invasive glaucoma surgery (MIGS) study ever conducted.

The trial is being conducted at 36 centers worldwide and includes more than 550 patients. An Investigator team at Keystone Research in Austin, Texas, led subject enrollment in the United States.

“As a busy glaucoma surgeon with experience in both traditional and the newer surgical approaches, I’ve been very impressed with Hydrus. I joined this study because of the science and engineering behind the device and its injector. The procedure is elegant and the implantation of the microstent has been safe and rewarding for my patients,” said Robert Marquis, M.D.

Ivantis has also reported that the positive two-year results from the international Hydrus II study recently were accepted into the journal Ophthalmology. The Hydrus II study was presented in its entirety at the American Academy of Ophthalmology (AAO) Meeting in October 2014, and is the first level-one evidence MIGS study to show an increasing treatment effect from one to two years relative to the control group. According to the company, the Hydrus II trial was designed to be highly similar to the Hydrus IV trial, though the Hydrus IV results alone will be the foundation of the efficacy analysis of the Hydrus device during the U.S. regulatory review process.

“This is a major accomplishment for Ivantis and represents significant progress for the Hydrus technology. It is important that we continue to look for new approaches to this challenging disease and I am looking forward to being able to offer the Hydrus upon its regulatory approval to my glaucoma patients,” noted Richard Lewis, M.D., a glaucoma and cataract specialist in private practice in Sacramento, Calif., as well as a scientific advisor and principal investigator for Ivantis.

The Hydrus IV study is a prospective, multicenter, single masked, controlled randomized study in patients with mild to moderate glaucoma undergoing cataract surgery. The patients were randomized 2:1 to Hydrus Microstent plus cataract surgery or cataract surgery alone, and will undergo follow-up evaluations at both the one and two year time points.

“We are proud to have completed this phase of the Hydrus IV study,” said Dave Van Meter, president/CEO of Ivantis. “We wish to acknowledge and congratulate the clinical investigators and study teams who made this milestone a reality. We now look forward to the important next steps of following these subjects and pursuing FDA (U.S. Food and Drug Administration) approval.”

The Hydrus Microstent, roughly the size of an eyelash, is placed through a minimally invasive, microsurgical procedure and is designed to reduce intra-ocular pressure by reestablishing the patient’s natural outflow pathway. The Hydrus creates a large opening through the traditional source of flow blockage (known as the trabecular meshwork) and it dilates and scaffolds the conventional pathway (known as Schlemm’s canal) through which fluid exits the eye. In addition to the Hydrus II and Hydrus IV trials, the Hydrus technology also is being studied internationally in both cataract and standalone glaucoma surgery settings in various types and severities of glaucoma. More than 2,000 procedures have been performed as part of clinical studies or global registries.

Ivantis 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, Ascension Health Ventures, Vertex Ventures, EDBI, Foresite Capital, GBS Ventures and MemorialCare Innovation Fund. The company is based in Irvine, Calif.