In the primary analysis at 12 months
76.3% of subjects
achieved ≥ 20% mean diurnal IOP reduction on the same or fewer number of medications vs baseline1,*
76.3% (95% CI = 65.8%, 86.8%); using observed data and failures for subjects with glaucoma-related secondary surgical intervention and multiple imputations for missing data (N = 65).
-6.4 mm Hg
mean diurnal IOP reduction from baseline ± 1.1 mm Hg (SE)1,*
-6.4 ± 1.1 (95% CI = -8.7, -4.2); using observed data and worst within-eye IOP for subjects with glaucoma-related secondary surgical intervention and multiple imputations for missing data (N = 65).
*Study eyes undergoing glaucoma-related secondary surgical intervention 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

Results of a prospective, multicenter, single arm, open-label, US clinical trial to evaluate the safety and effectiveness of the 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
Reduced IOP and medication use at month 121
Baseline 25.1( ± 3.7) mm Hg; 12-month 15.9 (± 5.2) mm Hg.1
Baseline 3.5 (± 1.0) medications; 12-month average 1.7 (± 1.5) medications.1
XEN® reduced mean IOP by ≥ 25% in 80.8% of eyes8,§
§ n = 42/52, overall baseline medications
15.4% (n = 10/65) of patients had no prior glaucoma procedures1
Refractory patients unresponsive to maximally tolerated medical therapy1
The XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector) is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
XEN® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened, previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active iris neovascularization, anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.
Warnings XEN® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following implantation of the XEN® Gel Stent to avoid the potential for implant damage.
Precautions Examine the XEN® Gel Stent and XEN® Injector in the operating room prior to use. Monitor intraocular pressure (IOP) postoperatively and if not adequately maintained, manage appropriately. Stop the procedure immediately if increased resistance is observed during implantation and use a new XEN® system. Safety and effectiveness of more than a single implanted XEN® Gel Stent has not been studied.
Adverse Events
The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).
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