Study population1
65 patients with refractory glaucoma1

Mean age: 70.0 years1

Prior cataract surgery: 45 (69.2%)1

Prior incisional glaucoma   procedure: 41 (63.1%) (eg, trabeculectomy, tube shunt, canaloplasty, trabeculotomy, AquaFlow)1
No prior glaucoma procedure and unresponsive to maximally tolerated medical therapy: 10 (15.4%)1

Mean cup-to-disc ratio: 0.81

Mean visual field mean deviation (MD) score: -15 dB1

Mean medicated IOP at baseline: 25.1 (± 3.7) mm Hg1

Mean IOP-lowering medications at baseline: 3.5 (± 1.0)1
primary efficacy measures7
Proportion of subjects at 12 months achieving ≥ 20% IOP reduction from baseline on the same or fewer number of medications than at baseline

Mean decrease in IOP from baseline to 12 months
primary Safety measures7
Procedure-related complications

Biomicroscopic slit lamp and ophthalmoscopy findings

Ocular adverse events
Indications
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.
IMPORTANT SAFETY INFORMATION
Contraindications
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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