Safety and efficacy findings from the XEN45 glaucoma implant

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Investigators assessed the XEN45 implant alone and in combination with phacoemulsification

A web of graphs, digital graphics and binary code visualising data. Image credit: ©Summit Art Creations – stock.adobe.com

The XEN45 implant is considered less invasive than traditional subconjunctival filtering procedures. Image credit: ©Summit Art Creations – stock.adobe.com

A team of Italian investigators led by Francisco Oddone, MD, reported that the XEN45 Implant (Allergan) used alone or in combination with phacoemulsification achieved comparable success rates and effectively and safely lowered the intraocular pressure (IOP) and the need for ocular hypertension medications.1 Dr Oddone is from the Scientific Institute for Research, Hospitalization and Healthcare, Fondazione Bietti, Rome.

This device may fill a gap in glaucoma therapy, the authors explained. The first therapeutic option to treat glaucoma is generally instillation of topical hypotensive; however, this may be inadequate to control the IOP in cases and surgery is needed. The authors presented data from the Italian XEN-Glaucoma Treatment Registry at the European Glaucoma Society Congress in Dublin, Ireland, during the poster session on Sunday 2 June.

The XEN45 implant, a filtering surgical procedure that diverts the aqueous humor from the anterior chamber to the subconjunctival space via the ab-interno approach, is considered less invasive than traditional subconjunctival filtering procedures.

The authors conducted a multicentre, prospective, observational study1 to evaluate the 1-year effectiveness and safety of the XEN45 implanted alone or in combination with phacoemulsification, in patients with glaucoma in the XEN-Glaucoma Treatment Registry (GTR). They also investigated the preoperative and intraoperative factors associated with surgical failure; surgical success was defined as IOP <18 mmHg and ≥20% reduction from preoperative IOP, over the 1-year follow-up.

XEN45 data analysis

The investigators reported the results from 239 eyes of 239 patients who were divided into two groups, ie, 144 (60.2%) eyes in the XEN-solo group and 95 (39.8%) eyes in the XEN+Phaco group.

The overall success rate achieved in both groups was achieved by 168 (70.3%) eyes; the difference between the groups did not reach significance (p = 0.07). The preoperative IOP decreased from a media of 23.0 mmHg (interquartile range [IQR], 20.0–26.0) to 14.0 mmHg (IQR, 12.0–16.0) at 1 year (P < 0.001); this represented an overall IOP reduction of 39.9% ± 18.3%.

The mean number of preoperative ocular hypotensive medications used by the patients also decreased significantly reduced from 2.7 ± 0.9 to 0.5 ± 0.9 at month 12 (P < 0.001).

An analysis of the factors associated with surgical failure showed that the preoperative IOP under 15 mmHg (hazard ratio [HR], 6.63; 95% confidence interval [CI], 2.61–16.84, P < 0.001) and the temporal position of the surgeon (HR: 4.25; 95% CI, 2.62–6.88, P < 0.001) were the culprits.

Regarding safety, no intraoperative complications developed in146 (61.1%) eyes; however, 91 (38.1%) and 56 (23.4%) eyes experienced at least one complication, respectively, early (< month 1) and late (≥ month 1) postoperatively. All of the complications were treated successfully and resolved without sequelae. Needling occurred in 55 (23.0%) eyes at least once during follow-up.

In commenting on their results, the investigators pointed out that the XEN-GTR is the first prospective, multicentre, real-world data collection with the aim of improving the understanding of the role of this technique in managing glaucoma.

The investigators concluded that the XEN45 implant, alone or in combination with phacoemulsification, had comparable success rates and effectively and safely lowered IOP and the need for ocular hypertensive medications.

The added knowledge from the study about the performance of the XEN45 was that, in a real-life setting, the XEN45 is effective and safe when implanted either alone or in combination with phacoemulsification and showed comparable success rates. Lower preoperative IOP values and the surgeon position may affect the success rate of the XEN45 implant. The XEN45 may be a valuable surgical option also in glaucoma patients with moderate to advanced visual field damage.

Reference
1. Oddone F, Roberti G, Giammaria S, et al. Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry. Eye. 2024;38:103–11; https://doi.org/10.1038/s41433-023-02642-5
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