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. 2025 Apr 28;14(9):3036.
doi: 10.3390/jcm14093036.

Efficacy and Safety of XEN63 Gel Stent Implant over 6 Months for Treatment of Glaucoma

Matteo Sacchi  1   2 , Sara Giammaria  3 , Gloria Roberti  3 , Davide Tomaselli  4 , Gianluca Monsellato  4 , Luca Agnifili  5 , Chiara Posarelli  6 , Giacomo Abbruzzese  7 , Lorenza Ronchi  2 , Filippo Tatti  8 , Stefano Dore  1   2 , Giuseppe Giannaccare  8 , Paolo Nucci  9 , Antonio Pinna  1   2 , Michele Figus  6 , Francesco Oddone  3
Affiliations

Efficacy and Safety of XEN63 Gel Stent Implant over 6 Months for Treatment of Glaucoma

Matteo Sacchi et al. J Clin Med. .

Abstract

Background/objectives: The efficacy and safety of the XEN45 gel stent implant in patients with glaucoma have been amply demonstrated. XEN63 is a new device that has been developed with a larger bore. This multicenter, observational, retrospective study assessed the efficacy and safety of XEN63 in patients with glaucoma. Methods: Medical records from six participating centers were screened to identify patients meeting the inclusion criteria. The primary outcome was mean IOP at 6 months after surgery. Results: The study included 114 eyes from 102 patients (XEN63 alone: 68 eyes, and XEN63 + Phaco: 46 eyes); 92% of patients had primary open-angle glaucoma. Baseline IOP for all patients was a median of 23.0 mmHg (IQR: 18.5-27.5 mmHg), which decreased significantly on day one post-surgery to 7.0 mmHg (IQR: 4.5-9.5 mmHg) and gradually stabilized at around 13.5 mmHg (IQR: 10.5-16.5 mmHg) by 6 months with no significant differences between groups at 6 months. The number of ocular hypertensive medications (OHMs) reduced significantly from a baseline median of 2.7 ± 1.1 to 0.5 ± 1.0 at 6 months in the entire cohort. The XEN63 alone group showed a significantly lower need for OHMs at 3 and 6 months. The surgical success rate was comparable between the two groups (54.4% vs. 47.8%, p = 0.05, XEN63 alone and XEN63 + Phaco). There was no statistically significant difference in survival outcomes between the XEN63 (0.59, 95% CI: 0.49-0.73) and XEN63 + Phaco groups (0.55, 95% CI: 0.42-0.72) (p = 0.89). Conclusions: In the largest study with XEN63 to date, the device appears to significantly decrease the IOP and the OHMs. Simultaneous XEN63 implant and phacoemulsification showed similar outcomes compared to XEN63 alone.

Keywords: XEN63 gel stent; glaucoma; therapy.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Changes in IOP (A) and number of OHMs (B) over 6 months in XEN 63 and XEN63 + Phaco groups. ns: >0.05; *: <0.05; **: <0.01; ***: <0.001.
Figure 2
Figure 2
Trends in the number of OHMs needed at 6 months by baseline IOP.
Figure 3
Figure 3
Changes in IOP (A) and number of OHMs (B) over 6 months in non-POAG and POAG groups. ns: >0.05.
Figure 4
Figure 4
Kaplan–Meier survival probability for all patients (A) and for the XEN63 and XEN63 + Phaco groups (B). Forest plot showing hazard ratio for failure considering different factors (C).
Figure 5
Figure 5
Kaplan–Meier survival probability of patients with open-angle (OH, POAG, PXF) for the XEN63 and XEN63 + Phaco groups.
See this image and copyright information in PMC

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