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Spotlight on XEN® Gel Stent

Kerri Fitzgerald

This Spotlight Series article is editorially independent content.

Glaucoma remains one of the leading causes of blindness globally, and intraocular pressure (IOP) reduction is currently the only modifiable factor that can be targeted to prevent or delay glaucoma progression. Although prostaglandin analogues are often the first-line topical glaucoma treatment, many individuals may eventually require multiple therapies to manage IOP.1 For ophthalmologists, the potential limitations of therapies and the complexities of disease progression present challenges.

XEN® Gel Stent: Minimally Invasive Filtering Surgery

Trabeculectomy is currently the gold standard glaucoma filtering procedure and one of the most effective IOP-lowering surgical options for the treatment of primary open-angle glaucoma (POAG).1 However, early and late complications are a concern following surgery.2 Glaucoma surgery has seen important advances in recent years with the development of minimally invasive or micro-incisional filtration surgery.3

XEN Gel Stent (Allergan, an AbbVie company) is an FDA-approved minimally invasive bleb surgery device. XEN 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 POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.4

Efficacy Data

XEN Gel Stent is a proven treatment option, with established efficacy and safety data.4-7

Pivotal Study

The safety and effectiveness of the XEN Gel Stent was evaluated in a prospective, multicenter, single-arm, open-label study. The study included 65 patients with refractory glaucoma in whom previous filtering or cilioablative procedures failed or IOP was unresponsive to maximally tolerated medical therapy.4

XEN Gel Stent reduced IOP from a mean medicated baseline of 25.1 mmHg to 15.9 mmHg at 12 months postoperative. The mean reduction in IOP-lowering medications decreased from 3.5 at baseline to 1.7 at 12 months.4 Furthermore, XEN Gel Stent provided consistent efficacy across a range of baseline pressures (see FIGURE).4,5

APEX Study

Two-year data from the prospective, nonrandomized, open-label, multicenter study assessed the long-term effectiveness and safety of XEN Gel Stent in patients with POAG who were uncontrolled on topical IOP-lowering medications. Patients were implanted with standalone XEN Gel Stent (n=120) or in combination with cataract surgery (phacoemulsification + implant; n=98). The modified intent-to-treat population included 202 eyes.6

Used alone or in combination with cataract surgery, XEN Gel Stent demonstrated efficacy over 2 years, as illustrated in the FIGURE. Changes in mean IOP and mean topical medications were statistically significant at all postoperative visits (P<.001). Mean medicated baseline IOP was reduced from 21.4 to 14.9 mmHg at 12 months and 15.2 mmHg at 24 months, with similar results in both treatment groups.6

5-Year Study

The 5-year study of the combination XEN Gel Stent implantation with phacoemulsification in patients with POAG demonstrated promising long-term efficacy.7

Based on a comprehensive analysis of 91 eyes, XEN Gel Stent showed a significant decrease in mean IOP from 20.2 mmHg at baseline to 15.4 mmHg at 5 years. The average number of ocular hypotensive medications also decreased from 2.9 to 1.5 during the same period.7

Safety and Tolerability

The most common postoperative adverse events observed in the pivotal study included best-corrected visual acuity loss of ≥2 lines (≤30 days, 15.4%; >30 days, 10.8%; 12 months, 6.2%), hypotony IOP <6 mmHg at any time (24.6%), IOP increase ≥10 mmHg from baseline (21.5%), and needling procedure (32.3%). No intraoperative complications or unexpected postoperative adverse events (AEs) were reported.4

The XEN Gel Stent has provided effective and sustained IOP reduction without requiring additional surgery for the majority (88%) of patients at 1 year.4,6 The 5-year study showed an acceptable safety profile, with low rates of intraoperative complications and AEs.7

For more information, visit https://hcp.xengelstent.com/.

References

  1. Sheybani A, Vera V, Grover DS, et al. Gel stent versus trabeculectomy: the randomized, multicenter, gold-standard pathway study (GPS) of effectiveness and safety at 12 months. Am J Ophthalmol. 2023;252:306-325. doi:10.1016/j.ajo.2023.03.026
  2. Ahmed IK, Vera V, Stalmans I, et al. Effectiveness and safety of the XEN45 gel stent compared to trabeculectomy in primary open-angle glaucoma: the Gold-Standard Pathway Study. BMJ Open Ophthalmol. 2025;10(1):e001696. doi:10.1136/bmjophth-2024-001696
  3. Traverso CE, Carassa RG, Fea AM, et al. Effectiveness and safety of Xen Gel Stent in glaucoma surgery: a systematic review of the literature. J Clin Med. 2023;12(16):5339. doi:10.3390/jcm12165339
  4. XEN® Directions for Use. AbbVie Inc. 2017.
  5. Grover DS, Flynn WJ, Bashford KP, et al. Performance and safety of a new ab interno gelatin stent in refractory glaucoma at 12 months. Am J Ophthalmol. 2017;183:25-36. doi:10.1016/j.ajo.2017.07.023
  6. 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;257(5):983-996. doi:10.1007/s00417-019-04251-z
  7. Ansari E. Five-year outcomes of ab interno Xen 45 gel stent implantation. Graefes Arch Clin Exp Ophthalmol. 2024;262(4):1263-1269. doi:10.1007/s00417-023-06294-9

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