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Ophthalmology:
Våra terapiområden

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      • XEN logotype
      XEN45 Directions for Use
      Mode of Action Video
      XEN63 Directions for use

      Efficacy and safety of XEN45®1

      XEN45 effectively lowered IOP and IOP-lowering medication count over 3 years, with a predictable and acceptable safety profile, when implanted via the traditional ab-interno technique.

      A multicentre, non-interventional, observational, retrospective chart review of medical records of patients treated with XEN™ alone or combined with phacoemulsification. Primary outcome measures included mean changes in IOP and IOP-lowering medication count from medicated baseline at 1, 2 and 3 years post implantation.1​​

      Intraoperative complications, adverse events of special interest (AESIs) and secondary surgical interventions (SSIs) were recorded.​​

      *p≤0.0003 vs baseline​

      ​

      Efficiancy mean

      Adapted from Reitsamer H, et al. 2021 (Fig1)1 by AbbVie.

      Efficiancy mean change

      Adapted from Reitsamer H, et al. 2021 (Fig1)1 by Abbvie..

      The safety and effectiveness populations included 212 eyes (primary and secondary) and 174 eyes (primary), respectively. Mean IOP and medication decreased from 20.7 mmHg and 2.5 at baseline (n = 163 primary/first implanted eyes) to 13.9 mmHg and 1.1 medications (n = 76) at 3 years postimplantation, respectively. Mean changes from baseline in IOP (-5.6, -6.2 and -6.6 mmHg) and IOP-lowering medication count (-1.8, -1.6 and -1.4) were statistically significant at 1, 2 and 3 years postimplantation, respectively (p≤0.0002). Results appeared comparable when implantation was performed with (n = 76) or without (n = 98) phacoemulsification. In primary eyes with 4-year IOP and medication count data (n = 27), mean IOP was 14.0 mmHg on 1.3 medications at 4 years postimplantation. Fifteen (7.1%) eyes had intraoperative complications, 31 (14.6%) experienced 46 postoperative AESIs, and 26 (12.3%) required SSI.​

      Effectiveness and safety of XEN63® in patients with primary-open-angle glaucoma2

      The effectiveness and safety of XEN63® was evaluated in a prospective, multicentre non-randomised clinical study in patients with POAG (N=80 eyes from 80 patients), either standalone (n=43) or in combination with phacoemulsification (n=37). The primary endpoint was the surgical success rate, defined as IOP lowering from preoperative values ≥20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications, based on Kaplan-Meier survival analysis.​

      Effectiveness of XEN63, primary endpoint2

      Xen63

      Kaplan–Meier survival analysis. The green area represents the 95% confidence interval in the overall study population. The lines show Kaplan–Meier survival curves for surgical success in eyes treated with XEN63 standalone and XEN63 + Phacoemulsification (Phaco). Mean hazard ratio: 1.28; 95% CI: 0.56 to 2.91; p = 0.5555.

      Xen63 tabell

      XEN63® alone and XEN63®+ phaco significantly reduced the mean preoperative IOP from 22.1 ± 4.9 and 19.8 ± 3.7 mmHg to 14.7 ± 5.3 mmHg and 13.8 ± 3.4 mmHg and significantly reduced postoperative mean IOP at every time point measured when compared to baseline levels (p < 0.0001). No significant differences were observed between the two study groups at any of the time-points. Vertical bars represent standard deviation.​

      The safety of XEN632

      Blue circle with text

      Preoperative number of ocular-hypotensive drugs was notably reduced from 2.3 ± 0.8 to 0.3 ± 0.7 drugs, from 2.5 ± 0.7 to 0.3 ± 0.7 drugs; and from 2.0 ± 0.8 to 0.3 ± 0.7 drugs, in the overall, XEN63-standalone, and XEN63 + Phaco groups, respectively.

      Blue circle with text

      Regarding safety, 34 eyes (42.5%) had transient hypotony at some point during the study, although only in one eye (1.2%) was clinically significant (N=80). ​

      Blue circle with text

      Four (5.0%) eyes underwent a needling, 4 (5.0%) eyes underwent surgical-bleb-revision, 1 (1.2%) eye required a device replacement and 1 (1.2%) eye a device removal due to maculopathy. ​

       

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      References and abbreviations

      1. Reitsamer H, Vera V, Ruben S, et al. Three-year effectiveness and safety of the XEN gel stent as a solo procedure or in combination with phacoemulsification in open-angle glaucoma: a multicentre study. Acta Ophthalmol 2021;100(1):233-245.
      2. Hussein IM, De Francesco T, Ahmed IIK. Intermediate Outcomes of the Novel 63-μm Gelatin Microstent versus the Conventional 45-μm Gelatin Microstent. Ophthalmol Glaucoma. 2023 Nov-Dec;6(6):580-591.
      3. Martínez‑de‑la‑Casa J M, Marcos‑Parra, Millá‑Griñó et al. Effectiveness and safety of XEN 63 in patients with primary-open-angle glaucoma. 2024 Feb 24;14(1):4561 ​

       

      IOP Intraoccular Pressure, POAG Primary Open Angle Glaucoma,

       

      Abbreviated DFU XEN Gel Implant.1,2​

       

      XEN INJECTOR​
      The XEN Injector is a single use mechanical delivery system for the XEN Gel Implant. The Gel Implant is preloaded in the XEN Injector which houses the Gel Implant during insertion and delivery into the eye. The XEN Injector allows the surgeon to advance and deliver the Gel Implant to the desired location.​

      INDICATIONS​
      The XEN Gel Implant is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed.​

      ​CONTRAINDICATIONS​
      The XEN Gel Implant is contraindicated under the following circumstances or conditions: Angle closure glaucoma, previous glaucoma shunt/valve in the target quadrant, presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant, active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis), active iris neovascularization or neovascularization of the iris within six months of the surgical date, anterior chamber intraocular lens, presence of intraocular silicone oil, vitreous present in the anterior chamber, impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure), known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde), history of dermatologic keloid formation.​

      WARNINGS​
      The following may occur in conjunction with the use of the XEN Gel Implant: Gel Implant migration, Gel Implant exposure or extrusion, ​
      Gel Implant blockage, choroidal effusion or hemorrhage, hypotony maculopathy, bleb related complications, choroidal detachment, conjunctival perforation, conjunctivitis, eye injury, fibrosis, high intraocular pressure, inflammation/irritation, irido-corneal touch, iridodialysis/iris rupture, iritis, lack of effectiveness, lacrimation, low intraocular pressure, malignant glaucoma, ocular pain, vision abnormalities, vision loss or endophthalmitis and other known complications of intraocular surgery (e.g., flat or shallow chamber, ​hyphema, corneal edema, macular edema, retinal detachment, vitreous hemorrhage, uveitis).​

      ​PRECAUTIONS​

      1. The XEN Gel Implant and Injector should be carefully examined in the operating room prior to use​

      2. The patient’s IOP should be monitored postoperatively. If the IOP is not adequately maintained after surgery, a therapeutic regimen or further intervention to reduce IOP should be considered.​

      3. In order to minimize trauma to the eye and associated complications, it is essential that the Gel Implant is placed in the proper subconjunctival location.​

      4. If increased resistance is observed at any time during the implantation procedure, stop the implantation procedure and use a new Injector.​

      ​

      1. XEN45 Directions For Use 5507-001 Dec-2019
      2. XEN63 Directions For Use 5501-001 May 2019

       

      SE-XEN-240016 v.1.0 November 2024