Ivantis initiates enrollment in Hydrus Microstent study for open angle glaucoma

Ivantis announced the enrollment of the first patient in the Hydrus IV study today. The Hydrus^TM Microstent is the world's first intracanalicular ("in the canal") scaffold for treatment of primary open angle glaucoma, a disease that afflicts over 70 million people worldwide and approximately 3 million people in the United States. The HYDRUS IV Study will include patients with glaucoma who are undergoing cataract surgery and also taking eye drop medication for their glaucoma. Per the study design, patients will either receive cataract surgery alone or cataract surgery plus the Hydrus Microstent. While the first phase of the study is intended to initially analyze results from a smaller number of patients, it is anticipated that more than 500 patients in over 25 centers globally will ultimately be included.

"Glaucoma surgery is in the midst of a renaissance and there has been particularly strong interest in the development of a glaucoma surgical procedure that can safely and effectively be performed adjunctively at the time of cataract surgery for patients with both conditions," said Dr. Kuldev Singh, Professor of Ophthalmology and Director of the Glaucoma Service at the Stanford University School of Medicine, and the Medical Monitor for the Hydrus IV Study.

"The scientific rigor that Ivantis has demonstrated in the development and investigation of the Hydrus will hopefully have a beneficial impact for glaucoma patients in both developed and developing countries. I look forward to seeing the results of this study," added Singh.

Ivantis' Hydrus device, roughly the size of an eyelash, is placed through micro-invasive procedure and is designed to lower pressure in the eye by reestablishing the patient's conventional outflow pathway. The majority of glaucoma patients have both a blockage and a collapse of the natural outflow pathway. The Hydrus device relies on a twofold mechanism of action that creates a large opening through the traditional source of flow blockage (known as the "trabecular meshwork"), and then dilates and scaffolds the conventional pathway through which fluid exits the eye (known as "Schlemm's canal").

Designed to be utilized sooner in the disease progression than most traditional surgical approaches, the Hydrus device may reduce or eliminate the need for glaucoma medications while effectively controlling intraocular pressure. Several studies have indicated that, within 6 months of diagnosis, as many as 50% of patients are not appropriately following their medication regimen.

"With the initiation of our US Pivotal Trial, we are pleased to take another significant step forward in our efforts to help bring additional interventional solutions to glaucoma sufferers and the surgeons who treat them," said Dave Van Meter, President and CEO of Ivantis.