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Safety and PROs in GPS Trial: Gel Stent vs Trab
Safety and PROs in GPS Trial: Gel Stent vs Trab

Arsham Sheybani, MD; Iqbal Ike K. Ahmed, MD, FRCSC; and Manjool Shah, MD

Gel Stent vs. Trabeculectomy RCT: A Discussion on Interventions and Patient Reported Outcomes in GPS
Gel Stent vs. Trabeculectomy RCT: A Discussion on Interventions and Patient Reported Outcomes in GPS

Arsham Sheybani, MD; Iqbal Ike K. Ahmed, MD, FRCSC; and Manjool Shah, MD

Overall Results of the Gel Stent vs. Trab RCT “Gold-standard Pathway Study: GPS
Overall Results of the Gel Stent vs. Trab RCT “Gold-standard Pathway Study: GPS

Arsham Sheybani, MD; Mark J. Gallardo, MD; and Davinder S. Grover, MD, MPH

Discussing Effectiveness and Safety of Gel Stent vs. Trabeculectomy Study
Discussing Effectiveness and Safety of Gel Stent vs. Trabeculectomy Study

Arsham Sheybani, MD; Mark J. Gallardo, MD; and Davinder S. Grover, MD, MPH

Audio Episodes from Abbvie

The Durability and Biocompatibility of the Gel Stent - Abbvie

The Durability and Biocompatibility of the Gel Stent

Arsham Sheybani, MD; Larissa Camejo, MD, PA; Xiongfei Liu, MD; and Richard Lewis, MD

Listen to Episode

XEN® Glaucoma Treatment System

INDICATIONS AND USAGE
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%).

For the full Directions for Use, please visit www.allergan.com/xen/usa.htm

XENG-US-00012-MC Approved 05/2023 ©AbbVie 2023. All Rights Reserved

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