Demonstrated efficacy with or without cataract surgery10

  • Changes in mean IOP and mean topical IOP-lowering medications were statistically significant at all postoperative visits (P < .001)10

APEX results: mean IOP in the low-to-mid teens through year 210

  • The change in mean IOP from medicated baseline was -6.5 ± 5.3 at month 12 and -6.2 ± 4.9 at month 24 (P < .001)10

Demonstrated efficacy from a range of baseline pressures14

≥ 20% reduction in IOP on same or fewer topical medications10

  • 83.7% and 85.1% of eyes ≤ 18 mm Hg IOP at 12 months and 24 months, respectively
  • 60.7% and 62.7% of eyes ≤ 15 mm Hg IOP at 12 months and 24 months, respectively

XEN® Gel Stent reduced or eliminated the need for topical IOP-lowering medications vs baseline10,*

Many patients were medication free for the entire 2-year study10

Reduction or elimination of IOP-lowering medications with XEN® Gel Stent has been proven through 2 years in APEX.10

APEX study safety data10

Intraoperative Complications (10/218)

4.6% Anterior chamber bleeding in 2.8% (6/218) of eyes was the most common

Postoperative ocular adverse events (65/218)

29.8%of eyes had 1 more Glaucoma-related SSI due to uncontrolled IOP (14/218; 6.4%) and hyphema (10/218; 4.6%) were most frequently reported

Persistent hypotony (0/218)

0% Defined as IOP < 6 mm Hg at 2 consecutive postoperative visits > 30 days apart

Numeric Hypotony (44/218)

20.2% Defined as IOP < 6 mm Hg (self-resolved) within the first 2 postoperative weeks

2.3% (5/218) were recorded as adverse events, all of which occurred within 1 week post implantation and self-resolved within 1 month

Ocular Serious Adverse Events (6/218) (5 in study eyes, 1 in untreated fellow eye)

2.8% Cataract aggravated, retinal disorder (central retinal vein occlusion reported at 12 months, without elevated IOP), conjunctival erosion (implant exposure), glaucoma-related SSI (due to hospitalization for surgery), endophthalmitis (reported 15 months after implantation), and high IOP with SSI (cyclodestructive procedure) in the untreated fellow eye (n = 1 each).

APEX study limitations10

  • Variability in perioperative regimens may have impacted study outcomes. At the time of initiation of this study, XEN® Gel Stent was new on the market and no best practices were established, so the study results also reflect the investigators’ learning curve with the surgery and the variation in preoperative and postoperative regimens associated with typical clinical settings
  • The study population underrepresented patients who were not White; < 5% were Asian or Black/African ethnicities. Black/African and Asian ethnicities have been reported to have increased risk for trabeculectomy failure
  • The APEX study design was nonrandomized and open label, which does not permit direct comparison to other MIGS and surgical techniques

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. Please click here for the full Directions for Use. Please call 1-800-433-8871 to report an adverse event.

Click here for XEN® Gel Stent Indications and Important Safety Information 

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. Please click here for the full Directions for Use. Please call 1-800-433-8871 to report an adverse event.