The international, multi-center, prospective study enrolling 69 patients with mild-to-moderate glaucoma is designed to evaluate the efficacy and safety of the Hydrus implant in two distinctly different surgical settings.
The study includes 29 patients who received the Hydrus device in conjunction with cataract surgery (combination surgery) and 40 patients who received the device alone (device-only surgery).
The Intracanalicular Implant is designed to reduce eye pressure by re-establishing the patient’s conventional outflow pathway, roughly the size of an eyelash and is placed through a minimally invasive microsurgical procedure.
The Hydrus device acts on a twofold mechanism of action that creates a large opening through the traditional source of flow blockage and then dilates and scaffolds the outflow pathway through which fluid exits the eye (known as Schlemm’s canal).
Ivantis president and CEO Dave Van Meter said the Hydrus has clearly helped patients in this study achieve lower IOP and be less reliant on eye drops.
"Our proprietary canal scaffold addresses the most critical area of outflow, and we are highly optimistic that the clinical results will continue to demonstrate this," Meter said.