IRVINE, Calif., Sept. 16, 2011 (GLOBE NEWSWIRE) -- Ivantis, a developer of novel intraocular devices designed to treat glaucoma by lowering the intraocular pressure (IOP) in the eye, announced today the 6-month results from its multi-center, international Hydrus I study at the European Society of Cataract and Refractive Surgery Meeting (ESCRS). The results are being presented by Manfred Tetz, MD (Berlin, Germany), PI and first European surgeon to implant the Hydrus device.
Ivantis' Hydrus™Intracanalicular Implant, roughly the size of an eyelash, is placed through a minimally invasive, microsurgical procedure and is designed to reduce eye pressure by reestablishing the patient's conventional outflow pathway. Most often, 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 relatively large opening through the traditional source of flow blockage (known as the "trabecular meshwork)", and then dilates and scaffolds the most critical quadrant of the outflow pathway through which fluid exits the eye (known as "Schlemm's canal").
The Hydrus I study was a prospective clinical trial at 6 centers that included 69 patients with mild-to-moderate glaucoma (the largest population of glaucoma) and was intended to assess the safety and efficacy of the Hydrus implant in two distinctly different surgical settings. 29 patients received the Hydrus device in conjunction with cataract surgery ("combination surgery"), while 40 patients received the device alone ("device-only surgery"). Six month follow up included measurements of change in IOP and change of medication burden to patient (measured as mean number of medications prescribed to control pressure).
According to Professor Tetz, in the "combination surgery" group (29 patients), the patients' average IOP decreased from 21.1 mmHg before surgery to 15.6 mmHg at 6 month-follow up, and medication burden was reduced from an average of 2.1 to 0.4 eye drops per patient. In the "device-only surgery" group, the average IOP decreased from 21.6mmHg before surgery to 16.9mmHg at 6 month follow-up, and average medication burden was reduced from 1.7 to 0.6 eyedrops per patient. 85% of patients in the "combination surgery" group and 70% of "device-only surgery" patients were free of medication at follow-up.
"These early clinical results with the Hydrus are very promising," said Professor Tetz. "Importantly, the results were consistent and stable on a per patient basis from 3 to 6 months, and variability of effect across patients was low – meaning it's consistent in its effectiveness per patient, and this was true in both groups. When we compare the site by site results, they are remarkably consistent, which shows reproducibility of outcomes across operators. Lastly, because of the two-armed design, this study takes important steps towards evaluating the impact of the implant itself – in addition to and in comparison with its impact with combined cataract surgery – towards the reduction of IOP. With over one-quarter of patients having already come in for their 1 year follow up and showing no evidence of degradation of effect, we look forward to the longer term data from this Hydrus I study
According to Dr. Thomas W. Samuelson, M.D., attending surgeon and glaucoma specialist at Minnesota Eye Consultants in Minneapolis and Medical Monitor of the study, "Certainly we find these early results compelling. The Hydrus implant significantly lowered IOP while also reducing the patient's medication burden. This was true even when the device was implanted as an isolated procedure without coincident cataract surgery. Such data is quite important clinically as we are well aware that cataract surgery alone can lower IOP. Accordingly, in combined procedure protocols, discerning the effect of cataract surgery on IOP from that of a glaucoma implant effect is critical in evaluating these new minimally invasive approaches. This study demonstrates that the Hydrus device alone can significantly lower IOP and reduce medications independent of cataract surgery. I look forward to the randomized trials that will investigate this procedure further."
"We are certainly quite encouraged by these 6 month results from our initial study," said Dave Van Meter, President and CEO of Ivantis. "The Hydrus has clearly helped patients in this study achieve lower IOP and be less reliant on eye drops. As an 'evidence-based' device company, we have invested heavily in basic science research in the development of this technology and understanding of this disease. Our novel and proprietary canal scaffold uniquely addresses the most critical area of outflow, and we are highly optimistic that the clinical results will continue to demonstrate this. Our goal is to provide the clinical community with not only tools, but answers, and, through the three randomized trials we have commissioned on top of Hydrus I, we will relentlessly serve our clinicians and patients over the next several years doing just that."
Approximately 60 million people globally have been diagnosed with glaucoma, and the predominant therapy in the developed nations is eye drops. In the United States alone, the cost of eye drops to patients and the health care system has been estimated at $2.5 billion annually. However, published studies suggest that, for a multitude of reasons, as few as 50% of patients adhere strictly to their prescribed medication regimen, while as many as 26% of patients stop taking their medication altogether within one year of their glaucoma diagnosis.
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 and Delphi Ventures.
Contact:
Gemma Cunningham
949-637-4296
gemma949@yahoo.com
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