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  • XEN45 appears safe and effective through 2 years

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    Review of: Efficacy and safety data for the XEN45 implant at 2 years: a retrospective analysis

    Gabbay I, Allen F, Morley C, et al. British Journal of Ophthalmology, July 2020

    Researchers report the efficacy and safety of XEN45 at 2 years.

    Study design

    This retrospective noncomparative chart review included 151 eyes that underwent XEN45 placement—with or without cataract surgery—with antifibrotic therapy at a single center between June 2015 and May 2017. The primary outcomes were IOP reduction and number of IOP medications taken at each time point. Failure was defined as needing further surgical treatment, excluding needling, or implant removal.

    Outcomes

    Approximately 62% of patients had a standalone XEN procedure. Mean IOP was 22 mm Hg at baseline, 15 mm Hg at 12 months (30.5% reduction) and 14.5 mm Hg at 24 months (34.6% reduction). The average antihypertensive glaucoma medication dropped from 3 at baseline to 0.3 and 0.5 at 12 and 24 months, respectively. By 12 months, 85% of patients did not require medication use while 75% did not require medication at 24 months.

    During the follow-up, 25 patients failed; 18 of these individuals underwent further surgery and 7 had the implant removed. Fifty-seven (38%) patients required needling.

    Limitations

    This is a retrospective chart review that did not include a comparative study arm and inherently has selection and information biases. The technique of XEN implantation has changed for many surgeons since this study was conducted (2015–2017), with many surgeons shifting from an ab-interno approach to an ab-externo approach or to an open XEN placement.

    Clinical significance

    Though this is not a randomized controlled study, this study shows real-world experience with the XEN45 gel stent implant. The XEN45 has gained significant traction over the last few years and this study further illustrates its efficacy and utility as a less invasive approach than traditional surgeries for IOP reduction. Despite what some U.S. insurance companies believe, it is a well-researched and well-documented procedure that is safer and often as effective as traditional open conjunctiva filtering procedures.