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XEN gel stent

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Last updated: August 5th, 2022

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Summary of Evidence

Efficacy

XEN alone

 

The XEN gelatin stent reduced IOP and medication use at 12 months without raising unexpected safety concerns.{Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh YJ, Nangia RS, Niksch B. Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months. Am J Ophthalmol. 2017 Nov;183:25-36.}

 

XEN vs Trabeculectomy

 

There was no difference in risk of failure and safety profiles between XEN with MMC and trabeculectomy with MMC.(Schlenker et.al., 2017){Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588.}

Evidence

1. Background

2. Safety and efficacy


The XEN® Gel stent was approved by the FDA in November 2016 for patients with refractory glaucoma who failed previous surgical treatment or in patients with primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.


2.1 Comparative effectiveness

2.1.1 XEN alone

Clinical Trial

2019 Reitsamer et.al.

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2019
Clinical Trial

The XEN gelatin implant effectively reduced IOP and medication-use over 2 years in medically uncontrolled POAG, with an acceptable safety profile.{Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996.}

  • Non-randomized prospective study of ab interno gelatin stent (XEN) with phacoemulsification vs stent implantation alone in medically uncontrolled moderate POAG (202 eyes).
  • Findings:
    • Mean medicated baseline IOP was reduced from 21.4  to 14.9 mmHg (12 months) and 15.2 mmHg (24 months), with similar results in both treatment groups.
    • The clinical success rate was 67.6% (12 months) and 65.8% (24 months).
    • 51.1 %(12 months) and 44.7% (24 months) of eyes were medication-free
Outcome Time period Phaco + XEN XEN alone
Change in mean IOP from baseline 24 months -6.5mmHg -6.2mmHg
Change in medication count from baseline 24 months -1.7 -1.5

Reitsamer et.al.
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Clinical Trial

2017 Grover et.al.

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2017
Clinical Trial

The XEN gelatin stent reduced IOP and medication use at 12 months without raising unexpected safety concerns.{Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh YJ, Nangia RS, Niksch B. Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months. Am J Ophthalmol. 2017 Nov;183:25-36.}

  • Single-arm prospective study of ab interno gelatin stent (XEN 45 Gel Stent) in refractory glaucoma (65 patients)
  • Findings at 12 months:
    • 75.4% reported ≥20% IOP lowering from baseline on the same or fewer medication
    • Mean IOP change from baseline was -9.1 mm Hg
    • Mean medication count decreased from 3.5  to 1.7.
  •  Common adverse effects included needling, non-persistent loss of best-corrected visual acuity, and transient hypotony (requiring no surgical intervention).

Grover et.al.
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2.1.2 XEN + cataract surgery vs XEN alone

Clinical Trial

2019 Gillmann et.al.

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2019
Clinical Trial

The XEN gel implant as a standalone or combined procedure with phacoemulsification demonstrated similar efficacy and safety results in Pseudoexfoliative and Primary Open Angle Glaucoma.{Gillmann K, Bravetti GE, Mermoud A, Rao HL, Mansouri K. XEN Gel Stent in Pseudoexfoliative Glaucoma: 2-Year Results of a Prospective Evaluation. J Glaucoma. 2019 Aug;28(8):676-684.}

  • Prospective interventional study of ab interno gelatin stent (XEN) implantation with phacoemulsification vs XEN implantation alone in Pseudoexfoliative and Primary Open Angle glaucoma (110 eyes of 85 patients).
  • Findings:
    • 51.4% (POAG) versus 57.1% (PEXG) eyes achieved complete success (Unmedicated IOP ≤ 16mmhg) at 2 years.
    • There was no difference in success rates between the 2 groups.
    • By 24 months, needling was performed in 42.8% (POAG) and 43.2% (PEXG), with an average time to needling of 162.8 and 134.9 days respectively.

Gillmann et.al.
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2.1.3 XEN vs trabeculectomy

Clinical Trial

2017 Schlenker et.al.

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2017
Clinical Trial

There was no difference in risk of failure and safety profiles between XEN with MMC and trabeculectomy with MMC.{Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588.}

  • Retrospective interventional cohort study of standalone ab interno gelatin stent (XEN Stent) vs trabeculectomy + Mitomycin C in uncontrolled glaucoma (354 eyes of 293 patients)
  • Findings:
    • The adjusted HR of failure of the microstent relative to trabeculectomy was 1.2 for complete success and 1.3 for qualified success.

Schlenker et.al.
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References

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