NONINFECTIOUS UVEITIS AFFECTING
THE BACK SEGMENT OF THE EYE AND
TREATMENT WITH OZURDEX®

Approved Use
OZURDEX® (dexamethasone intravitreal implant) isa prescription medicine that is an implant injected
into the eye (vitreous) and used to treat adults withnoninfectious inflammation of the uvea (uveitis)
affecting the back segment of the eye.
IMPORTANT SAFETY INFORMATION
When Not to Use OZURDEX®
OZURDEX® should not be used if you have any
infections in or around the eyes, including most viraldiseases of the cornea and conjunctiva, including active
herpes viral infection of the eye, vaccinia, varicella,
mycobacterial infections, and fungal diseases.
Please see additional Important Safety
Information throughout.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

HOW CAN NONINFECTIOUSUVEITIS AFFECTING THE BACKSEGMENT OF THE EYE AFFECTMY EYES?
Noninfectious uveitis affecting
the back segment of the eye is an
inflammatory disease.
Noninfectious uveitis:• Affects about
OUT OF EVERY

120 100,000
people per year

• Patients have a 5% riskof blindness or low
vision over 5 years

Although this disorder is considered rare,
those who develop it can be at a highrisk of recurrence. To help prevent this,it’s important to:• Get treatment promptly• Continue regular eye exams
and follow-ups• Take care of your overall healthSome factors can increase your risk ofdeveloping noninfectious uveitis affecting
the back segment of the eye, such as:• Smoking• An inflammatory disease
called sarcoidosis

Uveitisis pronounced
you-vee-eye-tis.

5%RISK23

WHAT ISNONINFECTIOUS UVEITIS?

UVEAL INFLAMMATION• Uveitis is inflammation of the uvea.
The uvea, also known as the uveal
tract, is the middle layer of the eye(see diagram)

Uveal tract
IrisCiliary
bodyChoroid

Retina• Uveitis can also affect the retina andblood vessels of the eye• Inflammation is caused by retinal cells,
your immune system’s white blood cells,
and the chemicals these cells release• Noninfectious uveitis means that
although the uvea is inflamed, nobacteria or viruses are found in the eye• The cause of the inflammation withnoninfectious uveitis is often unknown

4

Red text = areas of inflammation
associated with uveitis

5

HOW CAN NONINFECTIOUSUVEITIS AFFECT MY VISION?

You maysee spots(floaters)Your vision may become cloudy• Immune cells entering the vitreous
humor, which is the clear gel that fills theback of your eye, may cause vitreous
haze (cloudiness)• The haze can block light from reaching
the back of your eye
You may have significant vision loss
RANGE OF POSSIBLE VISUAL IMPAIRMENT

Mildblurry vision

6Moderateblurry vision

Uveitis can recur• New-onset uveitis occurs suddenly
and duration of inflammation could belimited. However, it is possible to haverecurrences over a period of months
or years• It is very important to receive medical
treatment each time noninfectious
uveitis affecting the back segment of
the eye appears
What can you do to prevent loss ofvision due to noninfectious uveitis?
Seek treatment right awayfor vision problems

Regulareyeexams

Appropriate
follow-up

Severeblurry vision

7

WHAT IS VISUAL ACUITY AND
HOW DOES IT RELATE TONONINFECTIOUS UVEITIS?
Visual acuity is the sharpness of yourvision. It is measured by the ability toread letters on an eye chart. What you
can see on the eye chart from 20 feetaway is recorded as a number.

20/40

20/20

You might have heard people refer to
20/20 vision as “perfect vision.” In fact,
a person with 20/20 vision can see what
an average person sees on an eye chartwhen standing 20 feet away.
Likewise, 20/40 vision means that, when
standing 20 feet away, the person can see
as well as an average person standing
40 feet away. On the eye chart to the left,
this means a person with 20/40 vision canread the letters in the line labeled 20/40
and above, but not the letters below.
• As vision worsens, the second
number increases• In 46 states, you needat least 20/40 vision
to obtain adriver’s license
Noninfectious
uveitis can worsen
your visual acuity,
but treatment may
help improve it.

A TYPICAL EYE CHART

89

HOW WILL MY NONINFECTIOUSUVEITIS BE TREATED?

There are several
treatment options fornoninfectious uveitisYour doctor will determine which is mostappropriate for you and your noninfectious
uveitis. These options include:• Oral medications (steroids)• Injections under the skin (biologics)• Eye drops (steroids)• Injections into the eye (steroids)– One type is an anti-inflammatory
injection, like OZURDEX®
(dexamethasone intravitreal implant)
IMPORTANT SAFETY INFORMATION (continued)
When Not to Use OZURDEX® (dexamethasone
intravitreal implant) (continued)
OZURDEX® should not be used if you have glaucoma
that has progressed to a cup-to-disc ratio of greaterthan 0.8.
Please see additional Important Safety
Information throughout.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf
10What is OZURDEX®?
OZURDEX® is a tiny implant that
releases an anti-inflammatory agent (acorticosteroid) called dexamethasone andis approved by the U.S. Food and Drug
Administration (FDA) to treat adults withnoninfectious inflammation of the uvea(uveitis) affecting the back segment of theeye. It is injected into the back of the eye,with minimal absorption into your body.
Your doctor will decide when and if areinjection of OZURDEX® is needed.
OZURDEX® IMPLANT SIZE COMPARISON
Implant*

Grain of rice

*Actual size

11

HOW WILL OZURDEX®
WORK INSIDE MY EYE?

OZURDEX® will be injected into thevitreous cavity in the back of your eye.
OZURDEX® treatment• Can help improve visual acuity(sharpness of vision)

The implant dissolves• Medication is slowly released
over time as OZURDEX® dissolves
153 people with noninfectious uveitis
affecting the back segment of the eyeparticipated in a 26-week clinical trial:• 77 patients received OZURDEX® and76 received sham (control) treatment• After an OZURDEX® treatment,improvements in vitreous haze andvision were shown throughout the26-week study

12• At week 8:– 47% (almost 5 in 10) of OZURDEX®
treated people had a vitreous hazescore of 0 (meaning no inflammation)compared to 12% (1 in 8) of controltreated people– 43% (4 in 10) of OZURDEX® treatedpeople gained greater than or equal
to 15 letters (3 or more lines) of vision
on an eye chart compared to 7%(1 in 14) of control-treated people– OZURDEX® treated people gained anaverage of 13.5 letters of vision on aneye chart compared to 1.8 letters forcontrol-treated people• Your own individual results may vary;
talk to your doctor

Please see additional Important Safety
Information throughout.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

13WHAT CAN I EXPECT WITH THE
OZURDEX® PROCEDURE?
AfterBefore• Speak with your doctor about anyquestions/concerns you may have• Arrange to have somebody take you toand from your appointment• Create a list of all the prescription andover-the-counter medications you takeDuring• The injection of OZURDEX® will only
take a few moments• You will be awake• Your doctor will clean and numb thesurface of the eye• Your doctor will inject OZURDEX® usinga special applicator that’s about the sizeof a pen• During the injection, you may feelpressure on the eye• You may then hear a click when yourdoctor presses the button that releases
the OZURDEX® implant into your eye14• Your doctor will check your eye, andthen you will be ready to go home• Over time, check for an improvement
in your vision. Your individual results
may vary• If your eye becomes red, sensitive
to light, painful, or develops a change
in vision, please contact your eye
doctor immediately• You may experience temporary visual
blurring after receiving an intravitreal
injection. Do not drive or use machines
until this has been resolved
Be sure to follow your doctor’s
instructions following the procedure.
IMPORTANT SAFETY INFORMATION (continued)
When Not to Use OZURDEX® (dexamethasone
intravitreal implant) (continued)
OZURDEX® should not be used if you have a posteriorlens capsule that is torn or ruptured.
Please see additional Important Safety
Information throughout.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

15WHAT SIDE EFFECTS CAN
HAPPEN WITH OZURDEX®?

OZURDEX® can cause cloudiness of
the lens that can lead to a cataract.

OZURDEX® can also cause your eye
pressure to increase.

• A cataract could form if you havemultiple treatments with OZURDEX®
• If that happens, your vision may
decrease, and you will need aprocedure to remove the cataract
and restore your vision– Ask your doctor about cataract
surgery. About 3.8 million surgeries
are performed in the United States
every year
• In clinical trials, after 26 weeks, cataracts
developed in about 15% out of 62
OZURDEX® patients with natural lenses
and 7% out of 55 sham (control)–treatedpatients with natural lenses• Your doctor will monitor youreye pressure• If there is an increase in eye pressure,then your doctor may prescribe you aneye drop that will need to be used daily• In most cases, the prescription eye drops
will take care of the increased pressure• In rare cases, the increase in eye
pressure may require surgery

IMPORTANT SAFETY INFORMATION (continued)
When Not to Use OZURDEX® (dexamethasone
intravitreal implant) (continued)
OZURDEX® should not be used if you are allergic
to any of its ingredients.
16

IMPORTANT SAFETY INFORMATION (continued)
Warnings and PrecautionsInjections into the vitreous in the eye, including
those with OZURDEX®, are associated with serious
eye infection (endophthalmitis), eye inflammation,increased eye pressure, and retinal detachments.
Your eye doctor should monitor you regularly after
the injection.
Please see additional Important Safety
Information throughout.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

17WHAT PATIENT ASSISTANCERESOURCES ARE AVAILABLE?
Will my insurance cover OZURDEX®?
How can I save on OZURDEX®
treatment?

Ask your doctor’s office to verify coveragethrough your specific insurance carrier.

AbbVie is committed to helping patientsgain access to and afford treatments.
There are cost-saving opportunities
available for OZURDEX®.
If you have commercial insurance andmeet other eligibility requirements, you
can pay as little as $0 for OZURDEX®.
Ask your doctor if you qualify. If you
are eligible, your doctor will enroll you.

IMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions (continued)
Use of corticosteroids including OZURDEX®
(dexamethasone intravitreal implant) may produce
posterior subcapsular cataracts, increased eyepressure, glaucoma, and may increase theestablishment of secondary eye infections due tobacteria, fungi, or viruses. Let your doctor know
if you have a history of ocular herpes simplex
as corticosteroids are not recommended inthese patients.
18

IMPORTANT SAFETY INFORMATION (continued)
Common Side Effects in Uveitis
The most common side effects reported include:
increased eye pressure, conjunctival blood spot, eyepain, eye redness, ocular hypertension, cataract,vitreous detachment, and headache.
Patient Counseling Information
After repeated injections with OZURDEX®, a cataract
may occur. If this occurs, your vision will decrease
and you will need an operation to remove the cataract
and restore your vision. You may develop increased
eye pressure with OZURDEX® that will need to be
managed with eye drops, and rarely, with surgery.
Please see additional Important Safety
Information throughout.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

19

LEARN MORE ABOUT OZURDEX®
AND NONINFECTIOUS UVEITISAT OZURDEX.COM

IMPORTANT SAFETY INFORMATION (continued)
Patient Counseling Information (continued)
In the days following injection with OZURDEX®
(dexamethasone intravitreal impant), you may be atrisk for potential complications including in particular,
but not limited to, the development of serious eye
infection or increased eye pressure. If your eye
becomes red, sensitive to light, painful, or develops
a change in vision, you should seek immediate carefrom your eye doctor. You may experience temporary
visual blurring after receiving an injection andshould not drive or use machinery until your vision
has resolved.
Please see accompanying full Prescribing
Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf© 2023 AbbVie. All rights reserved.
All trademarks are the property of their respective owners.
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