The FDA has approved the CyPass micro-stent system for use in combination with cataract surgery to reduce IOP in adult patients with mild to moderate primary open angle glaucoma, according to a news release from the agency’s Center for Devices and Radiological Health.
The CyPass micro-stent system model 241-S (Alcon, a division of Novartis) includes the CyPass micro-stent, a loading device and a stent delivery tool. The micro-stent is placed in the angle of the eye with the distal end residing in the supraciliary space to allow outflow of fluid from the anterior chamber through the distal end into the supraciliary and suprachoroidal spaces.
The approval was based on a randomized clinical trial of CyPass, which included 505 patients with primary open angle glaucoma. Of these 505 patients, 374 patients received the CyPass micro-stent in combination with cataract surgery, and 131 patients underwent cataract surgery alone.
Researchers evaluated the percentage of patients with a 20% or more reduction in mean diurnal IOP from baseline and adverse events during a 24-month period.
At 24 months, 72.5% of patients who received the CyPass micro-stent and 58% of patients who underwent cataract surgery alone achieved significant reduction in IOP.
The most serious reported adverse events included hypotony, maculopathy, peripheral anterior choroidal effusion, IOL subluxation and corneal compromise, and safety concerns included bleeding, inflammation, and damage to angle tissue, the release said.
Other complications included device malposition and movement and tube obstruction.