More than three-quarters of participants in the INFINITE trial achieved a 20% or greater reduction in mean diurnal IOP from baseline, on the same or a lower amount of ocular hypotensive medication, according to data presented at the 2021 American Academy of Ophthalmology meeting by Brian Flowers, MD, on behalf of the iStent Infinite Study Group.

The INFINITE study evaluated a 3-stent, standalone trabecular bypass procedure in patients with pseudophakic and phakic OAG who failed prior therapy. The prospective, multicenter, single-arm, open-label investigation did not require a preoperative medication washout. It included 72 eyes from 15 sites into which the 3-stent Glaukos iStent Infinite was inserted in a standalone procedure. These subjects had been either unresponsive to maximum tolerated medical therapy or their IOP was uncontrolled by 2 or more topical IOP-lowering medications, and they had more than 1 failed filtering glaucoma surgery or cilioablative procedure.

Ultimately, 76% of study participants achieved a 20% or greater reduction in mean diurnal IOP from baseline, on the same or lower amount of ocular hypotensive medication. More than 50% of subjects achieved a 30% or greater reduction in mean diurnal IOP from baseline, with a 13% mean reduction in medication burden at 12 months postoperatively. The iStent Infinite’s safety profile was also favorable, Dr. Flowers reported, with no explants, infections, device-related interventions, or hypotony reported through 12 months.