Ivantis Announces Results of Hydrus Implant Study
September 21, 2011
Last week, Ivantis announced the 6-month results from its multi-center, international Hydrus I study at the European Society of Cataract and Refractive Surgery Meeting (ESCRS).
The Hydrus(TM) 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. The Hydrus device relies on a twofold mechanism of action that creates a relatively large opening through the trabecular meshwork, and then dilates and scaffolds Schlemm’s canal.
The Hydrus I study 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).
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.
Click here to read the full press release.
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