PATIENT INFORMATION BROCHURE

iStent inject® Trabecular Micro-Bypass System

CAUTION: Federal law restricts this device to sale by, or on the order of, a physician© 2018 Glaukos CorporationPage | 1

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PATIENT INFORMATION BROCHURE
iStent inject Trabecular Micro-Bypass System
This document has been provided to assist in your understanding of the iStent inject
Trabecular Micro-Bypass System (referred to after this as iStent inject), which is one
option for managing your glaucoma. Please read the entire brochure and discuss thebenefits and risks with your eye care provider. Prior to undergoing any type of surgery, it isimportant to make sure your questions and concerns are fully addressed. The iStent injectprocedure is performed at the same time of cataract surgery and results in 2 identical stentdevices being implanted in the eye to help reduce your eye pressure.

Open-Angle Glaucoma and Intraocular Pressure
Glaucoma is a disease that damages the optic nerve in the back of your eye and causes
vision loss that worsens over time if not treated. There are different types ofglaucoma. The most common type is called primary open-angle glaucoma. The iStent
inject is specifically for patients with this particular type of glaucoma.

Your eyes produce a liquid (called aqueous humor) continuously in order to nourish theeye, which is essential for healthy eyes. With open-angle glaucoma the trabecularmeshwork in your eye (the drainage structure) may look normal, but the fluid does notflow out properly and the pressure in your eye increases. This increased eye pressure
can damage your optic nerve. Your eye doctor will measure the pressure in your eye. It
is important to measure eye pressure because most people with glaucoma have no early
symptoms or eye pain or there may be subtle changes, such as slight narrowing of yourperipheral (side) vision. If left untreated, over time glaucoma may result in permanentvision loss and blindness.

iStent inject
The iStent inject contains 2 tiny metal devices designed to stay in place inside the eye and© 2018 Glaukos CorporationPage | 2P/N 45-0230 Rev 1 06/2018

create a drainage channel to increase the flow of fluid. Figure 1 below shows how tiny thestents are by comparing those to a U.S. penny. These 2 stents are preloaded into a custom
injector, which is the instrument your surgeon uses to implant the stents in your eye. Duringcataract surgery, the 2 stents will be placed closely together to help reduce eye pressure.

Figure 1 – iStent inject compared to a penny

When implanted in the eye in the iStent inject can help lower your eye pressure by providing
a channel for the eye fluid to move out of the front chamber of the eye. Less fluid in thechamber means lower pressure. Figure 2 shows what the iStent inject looks like once it is
implanted in the eye.

Arrows show fluid
drainage pathway

Figure 2 – iStent inject implanted in the eye

Cataract Surgery with iStent inject
A cataract is a clouding of the lens in the eye that affects vision. Most cataracts are related tothe process of aging. Symptoms of cataracts may include cloudy or blurry vision, colors thatseem faded, difficulty with glare (such as in direct sunlight or with oncoming headlights) and© 2018 Glaukos CorporationPage | 3P/N 45-0230 Rev 1 06/2018

more frequent changes in glasses or contact lens prescriptions. Cataract surgery involves theremoval of the cloudy natural lens and replacement with an artificial (intraocular) lens (alsocalled an IOL). When you have cataract surgery along with the iStent inject as part of asingle procedure, the 2 stents are implanted in your eye immediately after your cataract isremoved and an IOL is implanted. Your eye surgeon will use the same surgical incisionthat was used to remove your cataract to insert the iStent inject.

Before Surgery
Before surgery your doctor will examine your eye, take measurements of your eye andeye pressure, and determine which type of intraocular lens (IOL) is best for you.
Depending on which medications you are taking, you may be asked to stop taking
them a few days before surgery or you may be asked to start new medications. Your
doctor may have additional recommendations for you. Before surgery make sure you
ask questions about anything you don’t understand.

Surgery Day
On the day of surgery, you will be given eye drops and possibly medicine to help you
feel more relaxed. You will also be given drugs to numb the eye so that you do not feelpain during the procedure. Your surgeon will perform cataract surgery using a
microscope that shows a magnified view of your eye. The natural lens is enclosed in abag-like structure called the capsule. The capsule is located behind the iris, which isthe colored part of your eye. Your surgeon will make a small incision in the outersurface of the eye and remove your cataract. Then an IOL will be implanted into thecapsule to replace your natural lens. Once implanted, the IOL performs just like yournatural lens to restore clear vision. Immediately after the cataract portion of the surgery
is completed, your surgeon will use the same incision to enter the eye with the iStent
inject injector instrument and the 2 stents will be implanted.

After the procedure, your eye surgeon will usually place a shield over your eye after
surgery to protect your eye. You will spend a short time in the outpatient recovery area
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and afterwards you will be able to go home to recover. You will not be allowed todrive home so you will need to plan to have someone drive you home. Your eye
surgeon will provide you with specific instructions after surgery.

After Surgery
You will be given eye drops to help your eye heal and prevent infection and your doctor
will give you specific instructions for when to use your eye drops. Your eye doctor will
examine you after surgery (usually the day after surgery) and check your eye pressure, which
may change during the first several days after surgery. Be sure to talk with your doctor to
make sure you understand the recovery process and postoperative instructions.

Your eye doctor should give you a Patient Identification card that contains important
information about your iStent inject. Please should keep this card in a safe place and show
it to your current and future healthcare providers.

Your eye doctor will monitor you after surgery to make sure your eye pressure iscontrolled. If needed, your doctor will recommend additional therapy, including
appropriate medication or other treatment, to control your eye pressure.

Other Treatment Options
The following treatments options are alternatives to the iStent inject:•Prescription eye medication•

Glaucoma laser treatment•

Trabecular bypass surgery (insertion of a stent to improve drainage of fluid bygoing around the blocked fluid drainage channels)•Stent implantation into the suprachoroidal space, which is an alternate exit
pathway deeper in the eye for fluid drainage•

Glaucoma surgeries to unblock fluid drainage channels, such as trabectome,canaloplasty, viscocanalostomy, trabeculotomy or filtration surgery•

Implantation of shunts or fluid drainage tubes to create an opening that allows© 2018 Glaukos CorporationPage | 5P/N 45-0230 Rev 1 06/2018

fluid to drain out of the eye
iStent inject Potential Benefits
The potential benefit of the iStent inject is the lowering of eye pressure, which may assist in
the management of your glaucoma. In a clinical study conducted in the United States, 380
patients received the iStent inject stents at the same time as cataract surgery and 118
patients had cataract surgery alone with no stents. These study patients were monitored for
2 years after their surgery. For each 100 patients in the study, approximately 76 patients
who received the iStent inject plus cataract surgery experienced significant lowering of theireye pressure, whereas approximately 62 patients who had cataract surgery only experienced
similar results.

iStent inject Potential Risks
The risks of iStent inject with cataract surgery are similar to the risks of having cataract
surgery alone. There are, however, some additional risks associated with iStent injectimplantation that were reported in a small number of patients. There is a small risk that theiStent inject stents may not be implanted successfully or implanted in the planned position.
Stents may become blocked over time and you may need to have a second procedure to clear
the blockage. Although uncommon, there are other risks that may be related to use of theiStent inject. These risks may include bleeding during surgery, inflammation, tissue trauma,changes in eye pressure that could affect vision, the feeling that there is something in youreye, eye pain, and progression of your glaucoma disease. General risks of eye surgery
include reactions to medicines, bleeding, infection, inflammation, vision changes, increased
eye pressure, and swelling of the cornea.

Medications or unplanned second surgeries may be needed to address these additional risks.
Please discuss all risks and benefits with your eye surgeon before your surgery.

During the clinical trial, only certain patients were able participate in the study.
Because of this it is important to note that the safety and effectiveness of the iStent© 2018 Glaukos Corporation

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inject has not been established in children and patients with the following circumstancesor conditions:oEyes with significant prior traumaoEyes in which the front of the eye is abnormaloEyes with chronic inflammationoEyes with glaucoma associated with vascular disorders (disorders related toblood vessels)

oEyes with pseudoexfoliative glaucoma (glaucoma caused by a build-up ofdeposits in the eye)oEyes with pigmentary glaucoma (glaucoma caused by flaking of iris pigment.
(Note that the iris is the colored portion of your eye)oEyes with secondary open-angle glaucoma

oEyes with glaucoma that have had prior cataract surgery

oEyes with uveitic glaucoma (glaucoma associated with inflammation in youreye)oEyes that have had prior surgery to treat glaucoma. Note, selectiveglaucoma laser treatment more than 3 months ago is acceptable.

oEyes with pressure greater than 24 mmHg that are using glaucoma medicationoEyes with pressure less than 21 mmHg or greater than 36 mmHg that are
not using glaucoma medicationoEyes in which cataract surgery complications occurredoWhen iStent inject stents are implanted without cataract surgery

The safety and effectiveness of use of more than or less than two iStent inject stents per eye
has not been established. iStent inject has not been shown to be an alternative to treatmentof glaucoma with medicine.

The following conditions may prohibit your doctor from having a sufficient view of your eyethat is required for safe and successful stent implantation: corneal haze or opacity (cloudinessin the front part of your eye), or any other conditions that may inhibit the view in the intended© 2018 Glaukos Corporation

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implant location.

Your doctor should perform an eye exam prior to surgery to exclude congenital anomalies(birth defects) of the area where the stent will be placed, including peripheral anterior
synechiae (PAS; tiny adhesions around the colored area of your eye), rubeosis (abnormalblood vessels), and any other abnormalities that could lead to improper placement of the stentand pose a hazard.

Patients with peripheral iridotomies of the iris (surgery of the colored area of your eye) are at
risk of stent dislocation within the eye, which can cause other problems.

The iStent inject is intended for implantation during cataract surgery, which may impact
corneal (transparent layer in front portion of your eye) health. Therefore, caution is advised ineyes with evidence of corneal problems or with risk factors for corneal problems following
cataract surgery (e.g., advanced age or severe cataract).

After the surgery, your doctor will give you an implant card with the appropriate information
filled in, and you should keep the card in a safe place, e.g., your wallet or purse, for futurereference. The implant card contains important information related to the iStent inject andthat the card should be shown to your current and future health care providers. The implantcard also identifies the iStent inject stent as “MR Conditional” (Magnetic Resonance). If you
need to undergo an MRI (Magnetic Resonance Imaging is a noninvasive test that usesmagnets), you should let your doctor know that you have an iStent inject stent implanted inyour eye, and show the doctor your implant card.

Your doctor will monitor your eye pressure after surgery. If your eye pressure is notadequately maintained after surgery, your doctor will consider medication or other treatment
to reduce your eye pressure.

The effectiveness of the iStent inject system has been demonstrated only in patients with mild© 2018 Glaukos Corporation

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to moderate open-angle glaucoma who had the stent implanted during cataract surgery.

The stent is made of implant grade titanium with a heparin (blood thinning) coating. The total
amount of heparin is estimated to be less than 0.9 microgram per stent, or approximately 0.01
to 0.02 units.
Is the iStent inject right for me?
iStent inject may be a good option if you have glaucoma that is not severe, and you areplanning to have surgery to remove your cataract. Your eye surgeon will examine your eye
and let you know if there is anything unusual about your eye’s anatomy or condition; forinstance, if the area in your eye is too narrow to implant iStent inject, or if there is acondition that may prevent your eye surgeon from seeing where iStent inject will beimplanted.

When should the iStent inject not be used?
The iStent inject Trabecular Micro-Bypass System should not be used in patients who haveone of the following conditions: angle closure glaucoma (quick or sudden increase in IOP);
traumatic, malignant, uveitic (inflammation of the eye tissue (uvea), or neovascular (related
to the iris (colored part of eye) and/or anterior chamber) glaucoma or noticeable birthirregularities of the anterior chamber (AC) angle; or retrobulbar (Orbital) tumor, thyroid eye
disease, Sturge-Weber Syndrome (neurological/nerve disorder marked by a distinctive portwine stain on the forehead, scalp or around the eye) or any other type of condition that may
cause elevated pressure in the veins of the eye (episcleral venous pressure).

iStent inject StudyIn the United States, a clinical study looked at the safety and effectiveness of iStent inject inlowering eye pressure in patients with primary open angle glaucoma who were undergoingcataract surgery. In this study, 380 patients received iStent inject at the same time as
cataract surgery, and 118 patients had cataract surgery only. Patients with iStent inject andcataract surgery achieved a significant lowering of their eye pressure more often thanpatients who only had cataract surgery. For each 100 patients in the study, approximately© 2018 Glaukos CorporationPage | 9

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76 patients who received the iStent inject plus cataract surgery experienced significant
lowering of their eye pressure, whereas approximately 62 patients who had cataract surgery
only experienced similar results. This lowered eye pressure lasted through the 2 year-longstudy. The overall safety of the patients who had iStent inject and cataract surgery patientswas similar through the 2 year-long study compared to the overall safety of the patients
who had cataract surgery only.

Eye Symptoms Reported by Patients after Surgery
Patients in the iStent inject clinical study were asked about eye symptoms they experienced
during the study. Some patients experienced worsening of some of these symptoms. This wasreported for a small number of patients who had cataract surgery and iStent inject stents
implanted, as well as for patients who only had cataract surgery. Many of these patients had
other eye conditions that may have contributed to their symptoms. Because the questionnaire
used was not developed with input from patients, the true rates for symptoms may bedifferent from the rates seen in this study. However, the rates of symptoms that got worse inthe study are shown in Table 1.

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Table 1: Rates of Worsening Eye Symptoms
2 Years after Surgery in the U.S. Clinical Study of iStent inject

Eyes that are sensitive to light
Eyes that feel gritty
Eyes that feel painful or sore
Blurry vision
Poor vision
Difficulty with reading
Difficulty with driving at night
Difficulty working with a computer or bank machine(ATM)
Difficulty watching TV
Eyes felt uncomfortable in windy conditions
Eyes felt uncomfortable in places or areas with low
humidity (very dry)Eye felt uncomfortable in areas that are air
conditioned

Cataract Surgery
and iStent inject

Cataract Surgery
Alone

Number ofPatients Out of100

Number ofPatients Out of
100

62221313

62
122371

132

1222

1

Ocular symptoms were considered as “worsening” if they were rated as being two grades worse thanat the beginning of the study© 2018 Glaukos CorporationPage | 11P/N 45-0230 Rev 1 06/2018

Table 2 shows eye symptoms that study patients reported experiencing “most of thetime” or “all of the time” 2 years after the surgery, even if their symptoms did notworsen during the study.

Table 2: Rates of Eye Symptoms Occurring “most of the time” or “all of the time”
2 Years after Surgery in the U.S. Clinical Study of iStent inject

Eyes that are sensitive to light
Eyes that feel gritty
Eyes that feel painful or sore
Blurry vision
Poor vision
Difficulty with reading
Difficulty with driving at night
Difficulty working with a computer or bankmachine (ATM)Difficulty watching TV
Eyes felt uncomfortable in windy conditions
Eyes felt uncomfortable in places or areas withlow humidity (very dry)Eye felt uncomfortable in areas that are air
conditioned

Cataract Surgery
and iStent inject

Cataract Surgery
Alone

Number ofPatients Out of100

Number ofPatients Out of
100

102143695123
1636113

1
45

253

3

1

Symptoms were included if they were reported at 2 years as occurring “most of the time” or “all of thetime”, even if the symptoms did not worsen during the study or were related to conditions that werepresent before the study started.

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229 Avenida Fabricante
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United States
tel: +1-949-367-9600
Glaukos® and iStent inject® are registered trademarks of Glaukos Corporation.

© 2018 Glaukos Corporation

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