A PROVEN PATHWAY TO LOWER IOP THAT MAY ALSO REDUCE TOPICAL MEDICATIONS

Mean diurnal IOP reduction from medicated baseline in advanced refractory patients1,*

All enrolled patients, ITT (N = 65)1

ACHIEVED ≥ 20% REDUCTION†

on the same or fewer medications

Patients who completed the 12-month visit (n = 52)7

ACHIEVED ≥ 25% REDUCTION

on the same or fewer medications

*Study eyes undergoing glaucoma-related secondary surgical intervention (SSI) 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

† 76.3% (95% CI = 65.8%, 86.8%); using observed data and failures for subjects with glaucoma-related SSI and multiple imputations for missing data (N = 65).1

‡-6.4 ± 1.1 (95% CI = -8.7, -4.2); using observed data and worst within-eye IOP for subjects with glaucoma-related SSI and multiple imputations for missing data (N = 65).1

§ -9.1 ± 5.9 (95% CI = -10.7, -7.5) for subjects who completed the 12-month visit (n = 52), excluding subjects with missing data (n = 4) and subjects requiring a glaucoma-related SSI (n = 9).7

ITT = intent to treat; SSI = secondary surgical intervention.

Documented in the XEN® Gel Stent clinical study1

Results across a range of baseline pressures1,11,*

*In the XEN® Gel Stent clinical study, baseline medicated IOP ranged from 20.0 to 33.7 mm Hg.7

XEN® Gel Stent provided consistent efficacy from a range of medicated baseline pressures.1,7

XEN® Gel Stent may reduce, and in some cases eliminate, the need for topical IOP-lowering medications1,7

MEAN REDUCTION IN IOP-LOWERING MEDICATIONS1

IOP-LOWERING MEDICATION REDUCTION AT 1 YEAR7,12

Eliminated

≥ 1 MEDICATION

Eliminated

≥ 2 MEDICATIONS

MEDICATION
FREE

Results of a prospective, multicenter, single-arm, open-label, US clinical trial to evaluate the safety and effectiveness of 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

XEN® Gel Stent is a reliable approach for powerful, sustained IOP reduction.1,10