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  • XEN 45 Gel Stent: Long-Term Effectiveness

    By Lynda Seminara
    Selected by Prem S. Subramanian, MD, PhD
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    Journal Highlights

    Clinical Ophthalmology
    2023;17:1223-1232

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    Marcos-Parra et al. reviewed three-year data to analyze the safety and effectiveness of the XEN 45 Gel Stent (Allergan), with or without concomi­tant phacoemulsification (phaco), for reducing IOP and medication burden in patients with open-angle glaucoma (OAG). In both surgical groups, these parameters were reduced significantly, and the safety profile was good. After the first post-op week, there was no sig­nificant difference in the IOP-lowering effect of XEN-solo and XEN-phaco.

    This single-center study involved pa­tients with OAG who received the XEN 45 stent alone or in conjunction with cataract surgery. The same surgeon performed the implantations while the patients were under local anesthesia. The stent was placed in the superior nasal quadrant using a standard ab in­terno technique. During the procedure, a 27-gauge needle was used to inject 0.1 mL of mitomycin C (0.01%) subcon­junctivally, under the Tenon capsule. The main outcome measure was the mean change in IOP from baseline to 36 months posttreatment for XEN-solo and XEN-phaco. Secondary end points included the mean change in number of glaucoma medications and the inci­dence of adverse events.

    Among the 154 eyes included in the analysis, 37 (24%) received XEN-solo and 117 (76%) underwent XEN-phaco. Overall, the mean IOP was lowered from 19.1 ± 5.0 mm Hg at baseline to 14.9 ± 3.8 mm Hg at month 36 (p < .0001). In the XEN-solo and XEN-phaco groups, IOP was reduced from 21.2 ± 6.2 mm Hg and 18.4 ± 4.3 mm Hg, respectively, to 14.3 ± 4.0 mm Hg (p < .0004) and 15.2 ± 3.7 mm Hg, respec­tively (p = .0009). The overall number of glaucoma medications was reduced from 2.1 ± 0.8 to 0.2 ± 0.6 (p < .0001). Thirty-six eyes (23.4%) required a nee­dling procedure, and 33 (21.4%) experi­enced bleb fibrosis; these were the most common complications. The frequency of surgical revision was significantly greater in the XEN-solo group.

    The authors concluded that the XEN 45 implant lowers IOP and decreases medication burden long term, whether used by itself or with cataract surgery. They noted that some doubts remain, including the cost-effectiveness of this procedure and the influence of differ­ent concentrations of mitomycin C on clinical outcomes.

    The original article can be found here.