Eyeworld Daily News

JULY 23, 2021 | EYEWORLD DAILY NEWS | 11 Allergan Xen 11 XEN ® helps put the power to control her IOP in your hands The XEN ® Gel Stent is minimally invasive fi ltering surgery that achieves powerful reduction of intraocular pressure (IOP). 1,2 • From a wide range of baseline pressures,* XEN ® achieved a mean IOP of 15.9 (± 5.2) mm Hg through 12 months (n = 52) 1, 2 • 76% of XEN ® patients achieved a ≥ 20% IOP reduction in the ITT group (N = 65) 1 • 81% of XEN ® patients achieved a ≥ 25% IOP reduction among those completing the 12-month visit (n = 52) 2 • Pivotal safety data included 0% intraoperative complications (0/65) and 0% persistent hypotony (0/65); transient hypotony † occurred in 24.6% of patients (16/65) 1 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 infl ammation, 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 signifi cant 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. 1. XEN ® Directions for Use. 2. Data on fi le, Allergan, 2016; Clinical Study Report R-020. THINK XEN ® AT THE POINT OF YOUR SURGICAL DECISION. FOR REFRACTORY GLAUCOMA © 2021 AbbVie. All rights reserved. XEN ® is a registered trademark of AqueSys, Inc., an AbbVie company. XenGelStent.com XEN143024-v2 07/21 009736 ITT = intent to treat. * In the XEN ® clinical study, baseline medicated IOP ranged from 20.0 to 33.7 mm Hg. 2 † No clinically significant consequences were associated with hypotony, such as choroidal effusions, suprachoroidal hemorrhage, or hypotony maculopathy. IOP < 6 mm Hg was defined as an adverse event, regardless of whether there were any associated complications or sequelae related to the low pressure. Thirteen cases occurred at the 1-day visit; there were no cases of persistent hypotony, and no surgical intervention was required for any case of hypotony. 1 Not actual patients. Visit Allergan booth #3813 for an on-site wet lab

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