Eyeworld

XEN ® ZONE I N R E F R A C T O R Y G L A U C O M A G E T T H E I R I O P I N T H E 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%). Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event. For clinical versatility, make XEN ® your first surgical option to lower IOP. IOP = intraocular pressure; MIGS = minimally invasive glaucoma surgery. Versatility That Matters From a wide range of baseline pressures, * XEN ® delivered IOP in the low-to-mid teens through month 12. 1,2 XEN ® achieved mean IOP of 15.9 (± 5.2) mm Hg through 12 months in the clinical study (n = 52). 2 XEN ® is appropriate for refractory open-angle glaucoma patients who are 2 : • Pseudophakic • Uncontrolled on maximum tolerated medical therapy • Inadequately controlled by prior surgery, including MIGS † • Undergoing cataract surgery or a stand-alone procedure © 2020 AbbVie. All rights reserved. XEN ® is a registered trademark of AqueSys, Inc., an Allergan affiliate. Allergan ® and its design are trademarks of Allergan, Inc XENGelStent.com XEN131457-v2 07/20 007093 References: 1. Data on file, Allergan, 2016; Clinical Study Report R-020. 2. XEN ® Directions for Use. † In the clinical study, prior surgery only included trabeculectomy, tube shunt, canaloplasty, and trabeculotomy. 2 * In the clinical study, baseline medicated IOP ranged from 20.0 to 33.7 mm Hg. 1 mm Hg

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