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

## TL;DR

This study shows that the XEN63 gel stent effectively lowers eye pressure and reduces medication use in glaucoma patients over six months.

## Contribution

The study presents the largest evaluation of the new XEN63 gel stent for glaucoma treatment to date.

## Key findings

- XEN63 significantly reduced intraocular pressure from 23.0 mmHg to 13.5 mmHg at 6 months.
- The number of ocular hypertensive medications decreased significantly from 2.7 to 0.5 at 6 months.
- XEN63 alone and combined with phacoemulsification showed similar surgical success rates and survival outcomes.

## 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.