Ivantis has reported the six-month results from its multicentre, prospective and international Hydrus I study, which was designed to evaluate the safety and efficacy of the Hydrus intracanalicular implant in two surgical settings.
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 re-establishing the patient's conventional outflow pathway.
The Hydrus device relies on a twofold mechanism that creates a relatively large opening through the traditional source of flow blockage, and then dilates and scaffolds the critical quadrant of the outflow pathway through which fluid exits the eye.
The study involved 69 patients. Twenty-nine received the Hydrus device in conjunction with cataract surgery (combination surgery group), while 40 patients received the device alone (device-only surgery group).
The six-month follow-up included measurements of change in IOP and change of medication burden to patient.
The data from the study showed that in the combination surgery group, the patients' average IOP decreased from 21.1mmHg before surgery to 15.6mmHg at six months, and the medication burden 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 six months, and average medication burden reduced from 1.7 to 0.6 eye drops per patient.
At a six-month follow-up, 85% of patients in the combination surgery group and 70% of device-only surgery patients were free of medication.