Mitosol®

Mitosol Has It All

Education

Getting Started with Mitosol

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Mitosol, the only FDA approved mitomycin-c for ophthalmology. For those who may not be familiar with Mitosol here’s some information to help you make a smooth transition.

The Mitosol Kit

The Mitosol Kit

Mitosol is packaged as a complete kit with everything needed to safely deliver the proper concentration of mitomycin-c.

The Key Benefits:

  • Always there when you need it without refrigeration or light shielding and a long shelf life.
  • A safer system for handling MMC.
  • A more consistent concentration.
  • Will help healthcare facilities achieve USP <800> compliance.

Learn How to Safely Use Mitosol

We have a resource center available that includes all the necessary information for Mitosol application. Here’s a video with step-by-step instructions on using the Mitosol Kit.

More Mitosol Information

If you have questions or need help you can contact us at anytime. Customer Service 877-393-6486.

WMI-043 Rev 02/2021

XEN® 45 Gel Stent

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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

EX-PRESS® Glaucoma Filtration Device Procedure

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What is an EX-PRESS® Glaucoma Filtration Device Procedure?

The EX-PRESS® Shunt procedure implants a stainless steel device (EX-PRESS® Glaucoma Filtration Device) under a scleral flap to allow for drainage of aqueous humor in order to relieve intraocular pressure due to glaucoma.

Photo showing Ex-PRESS Shunt implantation

The EX-PRESS® procedure is very similar to a trabeculectomy, in that a fluid path is created from the anterior chamber (inside of the eye) to the outside of the eye. The perceived value in the EX-PRESS® Shunt is that it creates a uniform and consistent sized channel for aqueous outflow into the intrascleral space. Like a trabeculectomy, the surgeon creates a scleral flap, then uses a 25-gauge needle to create a tunnel into the anterior chamber. The EX-PRESS® shunt is then implanted into the opening with a footplate flush to the surface of the sclera. The flap is brought down and sutured appropriately to regulate aqueous outflow.

Similar to a trabeculectomy, the surgeon may use mitomycin-c to suppress scarring that might disrupt fluid outflow. The procedure takes approximately 45-60 minutes. After the procedure, follow-up appointments will be scheduled to ensure intraocular pressure is at the optimal level. If needed, revisions to the flap can be made at that time. The goal of the procedure is to improve the drainage of aqueous humor out of the eye, thereby reducing excessive pressure compressing the optic nerve and causing vision loss.

EX-PRESS® Shunt Surgery Recovery

Patients with EX-PRESS® Shunt implants can expect a faster recovery than those with more invasive procedures like iridectomy of sclerectomy, according to a popular study² of trabeculectomy procedures done by Maris P, et al.  Maris also found a decrease in rates of hypotony due to the promotion of controlled drainage with the EX-PRESS® shunt.  Another study¹ highlighted a significant reduction in the risk of:

  • Inflammation
  • Pigment release
  • Bleeding from the iris
  • Vitreous prolapse

All of which resulted in fewer post-surgery visits due to complications.

Benefits of EX-PRESS® Shunt Implantation

The following table is a short-term comparison between the EX-PRESS® Glaucoma Filtration Device vs a traditional trabeculectomy.

CategoryEX-PRESS® DeviceTrabeculectomy
Effective IOP lowering²✔✔
Maintained ocular pressure²✔
Minimal inflammation and scarring³✔
Less hypotony and choroidal effusion²✔
Can be combined with cataract surgery✔✔
Fewer post-op visits¹✔
Faster visual recovery¹✔
One-year success rate∗80%51%

1. Good TJ, Kahook MY. Assessment of bleb morphologic features and postoperative outcomes after EX-PRESS® drainage device implantation versus trabeculectomy. Am J Ophthalmol. 2011 Mar;151(3):507-13.e1.

2. Maris P, et al. Comparison of trabeculectomy with EX-PRESS® miniature glaucoma device implanted under the scleral flap. J Glaucoma. Jan 2007;16(1):14-19.

3. Nyska A, et al. Biocompatibility of the EX-PRESS® miniature glaucoma drainage implant. J Glaucoma. 2003;12(3):275-280.

* de Jong L, Lafuma A, Aguadé AS, Berdeaux G. Five-year extension of a clinical trial comparing the EX-PRESS® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-533.

EX-PRESS® is a registered trademark of Novartis.

WMI-036 Rev 11/2019

Trabeculectomy Procedure

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Trabeculectomy Image.

What is a Trabeculectomy Procedure

A trabeculectomy is a surgical procedure performed by an ophthalmologist with the goal of relieving excessive pressure inside the eye, the leading symptom of glaucoma.

Trabeculectomy Steps

  1. The surgeon creates a hole from the inside of the eye to the outside of the eye, allowing fluid (aqueous humor) to drain out, lowering the pressure inside the eye.
  2. To prevent too much drainage, the surgeon creates a scleral flap that acts as a filter, regulating how much fluid can drain.

The fluid drains out from under the flap and is trapped between the sclera (the “white” of the eye) and the thin film covering the surface of the eye (conjunctiva), where it is absorbed by the body. By lowering the pressure inside the eye, compression on the optic nerve is reduced, preventing or slowing further damage to the optic nerve.

Procedure and Follow Up

The trabeculectomy procedure takes roughly an hour and is most often performed in an outpatient setting. It may be performed at the same time as cataract surgery, as some of the medications that treat glaucoma may contribute to cataract formation. It is common for the surgeon to apply mitomycin-c to the area which helps prevent scarring that could close the hole or flap. The surgeon will schedule several follow up appointments to make sure the intraocular pressure is at an optimal level and, if needed, make minor revisions to the flap to adjust the pressure.

Related Topics

WMI-034 Rev 11/2019

Why is Mitosol used during a trabeculectomy procedure?

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Over time, the sclera and the conjunctiva eventually “scar up” and the bleb is no longer functional.

Mitosol and Trabeculectomy

Trabeculectomy is performed to treat glaucoma, a disease that causes blindness, often due to increased pressure on the optic nerve caused by compromised outflow of aqueous humor from the anterior chamber of the eye. A portion of the trabecular meshwork is removed by the surgeon to create a bypass drain for the aqueous humor. The surgeon cuts the conjunctiva and separates it from the sclera, then creates a scleral flap to access the trabecular meshwork underneath. Once the portion of the trabecular meshwork is removed, aqueous outflow is established. The aqueous collects in the space between the sclera and conjunctiva, creating a bleb, where it is reabsorbed by the body.

Why Mitosol?

Mitosol is Mitomycin C, an antimetabolite (a chemotherapy agent) that inhibits the growth of fibroblasts that cause scarring of those tissues. The surgeon applies Mitosol between the sclera and conjunctiva to target the fibroblasts and prevent bleb failure.

WMI-035 Rev 11/2019

Does the contraindication for pregnancy include pregnant health care workers who work with Mitosol?

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Unfortunately, safe use during pregnancy has not been established.  The following is a statement from the American Academy of Ophthalmology regarding use of MMC in pregnant/lactating patients.

“Mitomycin C is an antifibrotic agent which is frequently applied in glaucoma surgery. A decrease of mean litter size and body weight and an increase of exencephaly in second gestation mice were associated with mitomycin use.29 There are no studies reporting the teratogenic effect of this drug in the human fetus, though the mechanism of action of the drug strongly suggests a possible teratogenic risk.” -EyeWiki

Although this addresses use in pregnant patients, the issue is exposure to the drug.  The Mitosol kit is designed to make the use of MMC in the operating room as safe as possible, however, there is always a potential for exposure, either by contact or inhalation.  Therefore, we recommend that pregnant or nursing health care workers avoid working with it if possible.  Due to the lack of information on chemotherapy and pregnant healthcare workers, our advice is it’s better to be safe than sorry.

WMI-038 Rev 01/2018