XEN® is available for the surgical management of refractory glaucoma. Click here for Indications and Important Safety Information ▲
XEN® is available for the surgical management of refractory glaucoma. Click here for Indications and Important Safety Information ▼
INDICATIONS
The XEN® Glaucoma Treatment System is available for the surgical management of refractory glaucomas, including cases where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
Who should not receive the XEN® Glaucoma Treatment System?
This surgical treatment should not be used if you currently have any of the following: angle-closure glaucoma where the drainage angle of the eye has not been surgically opened; a glaucoma drainage device previously implanted or scarring and pathologies of the conjunctiva (the clear membrane covering the white outer layer of the eye) in the area needed for this implant; eye inflammation (such as inflammation of the eyelids, conjunctiva, cornea, or uvea); abnormal formation of new blood vessels on the iris (the colored part of the eye) surface; artificial lens implanted in the anterior chamber (the space between your cornea, the outer transparent part of the eye, and the iris); silicone oil in your eye; and vitreous (the transparent jelly-like tissue that is found behind the lens) present in the anterior chamber.

What warnings should I be aware of? XEN® Gel Stent complications may include buildup of fluid between the choroid (inner layer of blood vessels) and the sclera (white outer layer of the eyeball), blood in the eye, very low eye pressure, implant moving to another part of the eye, implant exposure, wound leak, need for additional surgical intervention, and other eye surgery complications. The safety and effectiveness of the XEN® Gel Stent in neovascular, congenital, and infantile glaucoma has not been established. After the XEN® Gel Stent procedure, to help avoid the possibility of implant damage, avoid rubbing or pressing your fingers on the eye in the area where the XEN® Gel Stent was implanted.
,
What precautions should I be aware of? Before surgery, your doctor will check that the device and injector are not damaged. During surgery, your doctor will stop the procedure if he or she observes increased resistance during implantation and will use a new XEN® system. After surgery, your doctor should check and manage your eye pressure appropriately. The safety and effectiveness of implanting more than one XEN® Gel Stent in an eye has not been studied.

What are possible side effects? The most common side effects after surgery include reduction of vision, eye pressure becoming too low, an increase in eye pressure, and need for an additional surgical procedure in the eye to release scar tissue (needling) around the implant under the conjunctiva. Talk to your doctor about other possible side effects.

Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.


© 2021 AbbVie. All rights reserved. XEN® is a registered trademark of AqueSys, Inc., an AbbVie company. XenGelStent.com

XEN108484-v3   03/19   190872
XEN ® is available for the surgical management of refractory glaucoma. Click here for Indications and Important Safety Information ▲
XEN® is available for the surgical management of refractory glaucoma. Click here for Indications and Important Safety Information ▼
INDICATIONS
The XEN® Glaucoma Treatment System is available for the surgical management of refractory glaucomas, including cases where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
Who should not receive the XEN® Glaucoma Treatment System?
This surgical treatment should not be used if you currently have any of the following: angle-closure glaucoma where the drainage angle of the eye has not been surgically opened; a glaucoma drainage device previously implanted or scarring and pathologies of the conjunctiva (the clear membrane covering the white outer layer of the eye) in the area needed for this implant; eye inflammation (such as inflammation of the eyelids, conjunctiva, cornea, or uvea); abnormal formation of new blood vessels on the iris (the colored part of the eye) surface; artificial lens implanted in the anterior chamber (the space between your cornea, the outer transparent part of the eye, and the iris); silicone oil in your eye; and vitreous (the transparent jelly-like tissue that is found behind the lens) present in the anterior chamber.

What warnings should I be aware of?
XEN® Gel Stent complications may include buildup of fluid between the choroid (inner layer of blood vessels) and the sclera (white outer layer of the eyeball), blood in the eye, very low eye pressure, implant moving to another part of the eye, implant exposure, wound leak, need for additional surgical intervention, and other eye surgery complications. The safety and effectiveness of the XEN® Gel Stent in neovascular, congenital, and infantile glaucoma has not been established. After the XEN® Gel Stent procedure, to help avoid the possibility of implant damage, avoid rubbing or pressing your fingers on the eye in the area where the XEN® Gel Stent was implanted.

What precautions should I be aware of?
Before surgery, your doctor will check that the device and injector are not damaged. During surgery, your doctor will stop the procedure if he or she observes increased resistance during implantation and will use a new XEN® system. After surgery, your doctor should check and manage your eye pressure appropriately. The safety and effectiveness of implanting more than one XEN® Gel Stent in an eye has not been studied.

What are possible side effects?
The most common side effects after surgery include reduction of vision, eye pressure becoming too low, an increase in eye pressure, and need for an additional surgical procedure in the eye to release scar tissue (needling) around the implant under the conjunctiva. Talk to your doctor about other possible side effects.

Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.

Please see accompanying full Directions for Use or visit https://www.rxabbvie.com/pdf/xen_dfu.pdf


© 2023 AbbVie. All rights reserved.
All trademarks are the property of their respective owners.
US-XEN-230182  12/2023   024659
Glaucoma
WHAT IS GLAUCOMA?
Glaucoma is a complex eye disease that can damage the optic nerve and cause progressive, irreversible vision loss. In the most common forms of glaucoma, there is an increase of pressure inside the eye. When previous treatment has failed to reduce the pressure inside the eye, this is called refractory glaucoma.
FRONT OF EYE

An abnormal increase in pressure inside the eye occurs when fluid does not drain properly.
EYE PRESSURE FACT

The increased pressure from the front of the eye increases the pressure on the optic nerve at the back of eye.
Front of eye
OPTIC NERVE

Too much pressure can damage the optic nerve. This disease that damages the optic nerve is known as glaucoma.
How does eye pressure damage the optic nerve?
What are the symptoms of glaucoma?
For most people, open-angle glaucoma has no symptoms or early warning signs. Vision loss may not be noticeable at first because it starts gradually at the outer edges of the field of view. It may take years for noticeable sight loss to occur. Because the symptoms of open-angle glaucoma are so subtle, it’s important to have regular eye exams. Early detection and proper treatment can help reduce pressure inside the eye.
Who is at risk for glaucoma?
Glaucoma risk increases with age. You may also face increased risk if glaucoma runs in your family, if you are African-American or Latino, if you have diabetes, or if you are male.
How can high eye pressure be treated?

Prescription eye drops, oral medicines, laser treatment, surgery, or a combination of approaches are treatment options for high eye pressure. Eye drops are often prescribed, but they may not work for some patients as their glaucoma may be more difficult to treat.

When previous treatment has failed to reduce the pressure inside the eye, this is called refractory glaucoma. Your doctor may suggest alternative procedures that may reduce your eye pressure.

INDICATIONS
The XEN® Glaucoma Treatment System is available for the surgical management of refractory glaucomas, including cases where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
Who should not receive the XEN® Glaucoma Treatment System?
This surgical treatment should not be used if you currently have any of the following: angle-closure glaucoma where the drainage angle of the eye has not been surgically opened; a glaucoma drainage device previously implanted or scarring and pathologies of the conjunctiva (the clear membrane covering the white outer layer of the eye) in the area needed for this implant; eye inflammation (such as inflammation of the eyelids, conjunctiva, cornea, or uvea); abnormal formation of new blood vessels on the iris (the colored part of the eye) surface; artificial lens implanted in the anterior chamber (the space between your cornea, the outer transparent part of the eye, and the iris); silicone oil in your eye; and vitreous (the transparent jelly-like tissue that is found behind the lens) present in the anterior chamber.

What warnings should I be aware of?
XEN® Gel Stent complications may include buildup of fluid between the choroid (inner layer of blood vessels) and the sclera (white outer layer of the eyeball), blood in the eye, very low eye pressure, implant moving to another part of the eye, implant exposure, wound leak, need for additional surgical intervention, and other eye surgery complications. The safety and effectiveness of the XEN® Gel Stent in neovascular, congenital, and infantile glaucoma has not been established. After the XEN® Gel Stent procedure, to help avoid the possibility of implant damage, avoid rubbing or pressing your fingers on the eye in the area where the XEN® Gel Stent was implanted.

What precautions should I be aware of?
Before surgery, your doctor will check that the device and injector are not damaged. During surgery, your doctor will stop the procedure if he or she observes increased resistance during implantation and will use a new XEN® system. After surgery, your doctor should check and manage your eye pressure appropriately. The safety and effectiveness of implanting more than one XEN® Gel Stent in an eye has not been studied.

What are possible side effects?
The most common side effects after surgery include reduction of vision, eye pressure becoming too low, an increase in eye pressure, and need for an additional surgical procedure in the eye to release scar tissue (needling) around the implant under the conjunctiva. Talk to your doctor about other possible side effects.

Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.

Please see accompanying full Directions for Use or visit https://www.rxabbvie.com/pdf/xen_dfu.pdf