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XEN® 45 Gel Stent

October 10, 2017 by PINT Inc.

The XEN® 45 Gel Stent is a hydrophilic, non-inflammatory, subconjunctival gelatin stent.  FDA cleared in November 2016 for the management of refractory glaucoma, XEN® provides an ab interno approach, reducing the risk of bleb infection or leak, while bypassing the natural drainage pathways that often become obstructed and cause elevated IOP. The gelatin stent swells when hydrated, helping to maintain its intended position.  Adapting to the shape of the surrounding tissues, a permanent channel is formed, connecting the anterior chamber to the subconjunctival space.

Following pretreatment of the target area with Mitosol (mitomycin for solution) 0.2 mg/mL, the beveled needle tip of the injector is advanced through a peripheral corneal incision (1–2 mm anterior to the limbus) and across the anterior chamber toward the target quadrant, using an ab interno approach.  The needle tip is then aligned with the desired entry point of the trabecular meshwork and advanced through the trabecular meshwork (under gonioscopic guidance) and sclera.  The bevel is visualized as it enters the subconjunctival space.  The gelatin stent is then released in the subconjunctival space and the injector removed from the eye.  When properly positioned, approximately 2 mm and 1 mm of the stent length are visible in the subconjunctival space and anterior chamber, respectively.  After implantation, the conjunctiva is closed and the viscoelastic is irrigated and aspirated as needed. Seidel testing is then performed to ensure that there is no leakage of aqueous humor from the anterior chamber or conjunctiva.¹

Learn more about the XEN 45 Gel Stent

¹ Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh Y-J, Nangia RS, Niksch B, Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months, American Journal of Ophthalmology (2017), doi: 10.1016/j.ajo.2017.07.023

© 2018 Allergan. All rights reserved. XEN® is a registered trademark of AqueSys, Inc., an Allergan affiliate. Allergan® and its design are trademarks of Allergan, Inc.

WMI-055 Rev 11/2019

Filed Under: Education Tagged With: glaucoma, XEN

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INDICATION

Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Dosage & Administration

Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery and must be reconstituted prior to application. Sponges provided within the Mitosol® kit should be fully saturated with the entire reconstituted contents in a manner prescribed in the Instructions For Use. The sponge(s) should be applied to the treatment area for two minutes. Reconstituted Mitosol® should be used within one hour of reconstitution.

US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents issued and pending.

Product Information

Please click here for full Product Information for Mitosol®

IMPORTANT SAFETY INFORMATION
Contraindications

Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

Warnings & Precautions

Cell Death: Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or sclera damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. Hypotony: The use of mitomycin has been associated with an increased instance of post-operative hypotony. Cataract Development: Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation. Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use.

Adverse Events & Reactions

The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

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Mobius Therapeutics (makers of Mitosol) is now a part of Glaukos corporation.