ACHIEVED ≥ 20% REDUCTION†
on the same or fewer medications
A PROVEN PATHWAY TO LOWER IOP THAT MAY ALSO REDUCE TOPICAL MEDICATIONS
Mean diurnal IOP reduction from medicated baseline in advanced refractory patients1,*
*Study eyes undergoing glaucoma-related secondary surgical intervention (SSI) and/or removal of the XEN® Gel Stent prior to the 12-month evaluation were considered to be nonresponders.
Seven subjects in the study underwent needling procedures with mitomycin C; 4 of these subjects were considered responders.1
† 76.3% (95% CI = 65.8%, 86.8%); using observed data and failures for subjects with glaucoma-related SSI and multiple imputations for missing data (N = 65).1
‡-6.4 ± 1.1 (95% CI = -8.7, -4.2); using observed data and worst within-eye IOP for subjects with glaucoma-related SSI and multiple imputations for missing data (N = 65).1
§ -9.1 ± 5.9 (95% CI = -10.7, -7.5) for subjects who completed the 12-month visit (n = 52), excluding subjects with missing data (n = 4) and subjects requiring a glaucoma-related SSI (n = 9).7
ITT = intent to treat; SSI = secondary surgical intervention.
XEN® Gel Stent may reduce, and in some cases eliminate, the need for topical IOP-lowering medications1,7
Results of a prospective, multicenter, single-arm, open-label, US clinical trial to evaluate the safety and effectiveness of XEN® Gel Stent in refractory glaucoma subjects (N = 65) where previous filtering or cilioablative procedures failed, or IOP was unresponsive to maximally tolerated medication. Medication washout was not performed; all IOP-lowering medications were discontinued on the day of surgery.1