AN ESTABLISHED PATHWAY WITH A DEMONSTRATED RISK/BENEFIT RATIO

12-month pivotal study safety data1

XEN® Gel Stent has a favorable risk/benefit ratio, with low rates of intraoperative complications and postoperative vision-threatening 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%), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).

Intraoperative complications (0/65)

0%

  • 0% surgical complications
  • 0% shallow anterior chamber with peripheral iridocorneal touch
  • 0% flat anterior chamber with iridocorneal touch extending to the pupil
  • 0% choroidal hemorrhage or effusion
  • 0% hyphema
  • 0% conjunctival perforation
  • 0% iris/lens damage

Persistent hypotony* (0/65)

0%

Defined as IOP < 6 mm Hg at 2 visits > 30 days apart

Transient hypotony* (16/65)

24.6%

Defined as IOP < 6 mm Hg at any time

Postoperative complications of clinical interest

  • 1.5% bleb leak (without operative room or slit lamp revision)
  • 0% bleb leak (with operative room or slit lamp revision)
  • 3.1% choroidal effusion (extending posterior to equator, without blood)
  • 0% choroidal effusion (all others)
  • 0% chronic pain (present > 3 months)
  • 1.5% corneal edema grade 3 or grade 4 (> 30 days postoperatively)
  • 0% endophthalmitis
  • 4.6% hyphema (≥ 2 mm in height [layered] at any time)
  • 0% hyphema (present or arising > 30 days)
  • 0% hypotony maculopathy
  • 1.5% macular edema
  • 32.3% needling procedure
  • 0% ptosis
  • 0% significant iris injury or atrophy
  • 0% strabismus
  • 0% vitreous hemorrhage
  • 9.2% wound leak/dehiscence

*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.

XEN® Gel Stent provided effective and sustained IOP reduction without the need for additional surgery for most patients (88%) at 1 year.1,10