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Does mitomycin-C concentration have any influence on XEN45 gel stent outcomes in a real-world setting?

  • Glaucoma
  • Published:
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Abstract

Background

To compare the effectiveness and safety of XEN45 implanted with mitomycin-C (MMC) 0.01% versus (vs) XEN45 implanted with MMC 0.02%.

Methods

Retrospective and single-center study conducted on consecutive patients with open-angle glaucoma or ocular hypertension who underwent XEN45-implant, either alone or in combination with cataract surgery. The primary end-point was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit.

Results

Fifty-five patients (63 eyes) were included. Thirty-seven (58.7%) eyes underwent surgery with MMC 0.01% and 26 (41.3%) ones with MMC 0.02%. In the overall study sample, the mean (standard error) IOP was significantly lowered from 17.6 (0.7) mm Hg at baseline to 12.6 (0.3) mm Hg at month 12. The IOP was significantly lowered from 17.3 (15.4 to 19.2) mm Hg and 17.9 (16.1 to 17.8) mm Hg at baseline to 12.3 (11.3 to 13.3) mm Hg and 13.1 (12.3 to 13.9) mm Hg at month 12 in the MMC 0.01% and MMC 0.02% groups, respectively; p < 0.0001 each. The mean number of ocular-hypotensive medications significantly decreased from 2.1 (1.9 to 2.3) at baseline to 0.2 (0.04 to 0.3) at month 12, p < 0.0001, with no significant differences between MMC 0.01% and MMC 0.02% groups, p = 0.5181. At month 12, 50 (80.6%) eyes had functioning blebs. Regarding safety, 18 (28.6%) eyes have experience adverse events.

Conclusion

XEN45, either alone or in combination with cataract surgery, showed a good effectiveness and safety profile. MMC dose had no influence on the IOP lowering, which may support the use of the lowest dose.

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Data availability

Data not here published are obtainable on reasonable request from the corresponding author.

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Acknowledgements

Writing and editorial assistance was provided to the authors by Antonio Martinez (MD) of Ciencia y Deporte ltd.

Funding

Medical writing services and editorial assistance were covered by Allergan, an AbbVie company (Grant number: not applicable).

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Authors and Affiliations

  1. Ophthalmology Department, Hospital Universitario de Fuenlabrada, Camino del Molino, 2, 28942, Fuenlabrada, Madrid, Spain

    Natalia Monja-Alarcón, Susana Perucho-Martínez, Miriam Buenasmañanas-Maeso & Nicolás Toledano-Fernández

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  1. Natalia Monja-Alarcón
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  2. Susana Perucho-Martínez
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  3. Miriam Buenasmañanas-Maeso
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  4. Nicolás Toledano-Fernández
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Contributions

All authors met the ICMJE authorship criteria. All authors made substantial contributions to conception, design, analysis and interpretation of data, contributed to writing the article, provided critical revision of the manuscript, and approved the final version.

Corresponding authors

Correspondence to Natalia Monja-Alarcón, Susana Perucho-Martínez or Miriam Buenasmañanas-Maeso.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Ethic Committee of the Fuenlabrada University Hospital and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Consent to participate

The study protocol was approved by the Ethic Committee of the Fuenlabrada University Hospital (APR 20/05). Since it was a retrospective study, which reviewed medical charts, the Ethic Committee of the Fuenlabrada University Hospital waived the need for written informed consent.

Conflict of interest

Dr. Susana Perucho has received a grant from Allergan during the conduct of the study.

Neither honoraria nor payments were made for authorship of this article.

Drs. Natalia Monja-Alarcón, Miriam Buenasmañanas-Maeso, and Nicolas Toledano-Fernández certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.

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Monja-Alarcón, N., Perucho-Martínez, S., Buenasmañanas-Maeso, M. et al. Does mitomycin-C concentration have any influence on XEN45 gel stent outcomes in a real-world setting?. Graefes Arch Clin Exp Ophthalmol 260, 2649–2661 (2022). https://doi.org/10.1007/s00417-022-05603-y

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