2-Year Data From the APEX Study

(mITT Population)8,*

View 12-Month Pivotal Study Data

21.4 (±3.6) mm Hg

Baseline mean medicated intraocular pressure (IOP)

14.9 (±4.5) mm Hg

Month-24 mean IOP (primary outcome)

15.2 (±4.2) mm Hg

Month-24 mean IOP

The change in mean IOP from medicated baseline was -6.5 ± 5.3 at month 12 (primary outcome) and -6.2 ± 4.0 at month 24 (P < .001) in the mITT population (N = 202).

*Prospective, nonrandomized, open-label, multicenter, 2-year European study evaluated the effectiveness of the XEN® Gel Stent as primary surgical intervention in reducing IOP and IOP-lowering medication count in 200 patients (219 eyes) with medically uncontrolled, moderate primary open-angle glaucoma. Eyes with medicated baseline IOP 18 to 33 mm Hg on 1 to 4 topical IOP-lowering medications were implanted with XEN® alone or phaco + XEN®. The modified intent-to-treat population included all enrolled eyes with verified informed consent documentation that received a XEN® implant and met the IOP and IOP-lowering medication count inclusion criteria.

This study was funded by Allergan® plc (Dublin, Ireland; formerly AqueSys, Inc.). Herbert Reitsamer has received consulting honoraria from Allergan®. Chelvin Sng has received consulting honoraria from Allergan®, Glaukos (San Clemente, California), Alcon (Fort Worth, Texas), and Santen Pharmaceuticals (Osaka, Japan). Vanessa Vera has received consulting honoraria from Allergan®. Keith Barton has received consulting honoraria from Alcon, Allergan® and Glaukos. Ingeborg Stalmans has received consulting honoraria from Allergan®. Markus Lenzhofer declares that he has no conflict of interest.

APEX study limitations8

  • Variability in perioperative regimens may have impacted study outcomes. At the time of initiation of this study, XEN® 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

mITT = modified intent-to-treat; phaco = phacoemulsification with intraocular lens replacement.

DECREASES IN MEAN IOP FROM MEDICATED BASELINE WERE SIMILAR WITH OR WITHOUT CATARACT SURGERY8

Similar results were observed in both treatment groups at all postoperative visits up to 24 months (P  > .4, between-group comparisons).

POST HOC ANALYSIS: 2-YEAR RESULTS ACROSS A RANGE OF BASELINE PRESSURES9

REDUCTION IN MEAN NUMBER OF IOP-LOWERING MEDICATIONS VS BASELINE (mITT POPULATION)8,†

51.1% (91/178) and 44.7% (72/161) of eyes were topical medication–free at months 12 and 24, respectively.

†A reduction of 1.7 ( ± 1.3 ) in the mean number of IOP-lowering medications vs baseline was reported at month 12 (primary outcome, P < .001) and a reduction of 1.5 ( ± 1.4 ) was reported at month 24 (P < .001).

APEX 2-YEAR STUDY SAFETY DATA8

Intraoperative Complications (10/218)

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

Persistent Hypotony (0/218)

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

Postoperative Ocular Adverse Events (65/218)

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

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 Criteria8

Two-year, prospective, nonrandomized, open-label, multicenter study

STUDY POPULATION

  • 200 adult patients (219 eyes) with moderate primary open-angle glaucoma uncontrolled on topical therapy
  • Mean age: 71.8 (± 10.5) years
  • Prior cataract surgery: 25 (13.5%)
  • Mean visual field mean deviation (MD) score: -8.0 (± 8.9) dB
  • Mean medicated IOP at baseline: 21.4 (± 3.6) mm Hg
  • Mean IOP-lowering medications at baseline: 2.7 (± 0.9)

PRIMARY EFFECTIVENESS MEASURES6

  • Changes in mean IOP and mean number of topical IOP-lowering medications in the study eyes from baseline to month 12

- These parameters were also assessed at all other postoperative visits up to 24 months (secondary effectiveness measures)

PRIMARY SAFETY MEASURES6

  • Intraoperative complications
  • Monocular best-corrected visual acuity
  • Biomicroscopic slit lamp and ophthalmoscopy findings
  • Postoperative adverse events (each postoperative visit through month 24)

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® 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.