DIABETIC MACULAR EDEMA (DME)
AND TREATMENT WITH OZURDEX®

Approved UsesOZURDEX® (dexamethasone intravitreal implant) is aprescription medicine that is an implant injected into theeye (vitreous) and used to treat adults with diabetic
macular edema.
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 viral diseases ofthe cornea and conjunctiva, including active herpes viral
infection of the eye, vaccinia, varicella, mycobacterialinfections, and fungal diseases.
Please see additional Important Safety Information
on pages 10-19.

HOW CAN DIABETESAFFECT MY EYES?

1.5

millionAmericans

are diagnosed withdiabetes every year

• Diabetes is a lifelong condition thatmust be managed with insulin or othermedication, depending on whether you
have type 1 or type 2 diabetes

1#of vision loss incause working-age adults
is diabetic eye disease• To help manage complications ofdiabetes, such as diabetic eye disease,
it’s important to see your primary care
physician regularly and keep your blood
sugar and blood pressure (hypertension)under control

2Diabetic
retinopathy (DR)• If you have uncontrolled, high blood
sugar, over time it can damage thetiny blood vessels in your eye—this is
known as diabetic retinopathy (DR)• All people with diabetes are at risk fordiabetic eye diseases like DR– The longer you have diabetes, thegreater your risk

Please see additional Important Safety Information
on pages 10-19.

3WHAT IS DME?

When DR damages the blood vessels ofthe eye, it can lead to diabetic macularedema (DME)• DME affects the retina, the part of the eyethat sends visual images to the brain

50%

OPTIC BLOODNERVE VESSELS

A normaleye seen
with special
photography

DME develops in about
half of people with DR

Many factors contribute to DME, but
inflammation plays a large role.
• Fluid leaks from the damaged bloodvessels and causes swelling of the macula,
the part of the retina responsible for sharp,
central vision• The leakage also causes deposits to formin the eye, which your doctor can see witha special type of photography (shown tothe right)

MACULADEPOSITS FROMLEAKING FLUID

An eye with
DME seen
with special
photography

Please see additional Important Safety Information
on pages 10-19.
45

HOW CAN DME AFFECT
MY VISION?
DME can affect your visual acuity and leadto a loss of vision or blurry vision.
RANGE OF VISUALIMPAIRMENT DUE
TO DME

Mild
blurry vision

Moderate
blurry vision

Some symptoms of DME are:
• Blurry vision• Faded colors• Distorted vision
DME can cause your vision to change
so slowly that you might not even notice
any symptoms. If you have diabetes,it’s important to get your eyes checked
regularly as recommended byyour doctor.

WHAT YOU CAN DO TO
PREVENT OR DELAY LOSS OF
VISION DUE TO DMEGood management of diabetes,
including your blood sugar andblood pressure
Regular eye exams

Severeblurry vision

Appropriate follow-up

Please see additional Important Safety Information
on pages 10-19.
67WHAT IS VISUAL ACUITY AND
HOW DOES IT RELATE TO DME?

Visual acuity is the sharpness of your vision.
It is measured by the ability to read letterson an eye chart. What you can see on theeye chart from 20 feet away is recorded asa number.

You might have heard people refer to
20/20 vision as “perfect vision.” In fact, aperson with 20/20 vision can see what anaverage person sees on an eye chartwhen standing 20 feet away.
Likewise, 20/40 vision means that, whenstanding 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.

20/40

20/20

A TYPICAL EYE CHART• As vision worsens, the second
number increases• In 46 states, you needat least 20/40 vision
to obtain adriver’s license
DME can worsen
your visual acuity,
but treatment canhelp improve it.

Please see additional Important Safety Information
on pages 10-19.
89HOW WILL MY DME
BE TREATED?
WHAT IS OZURDEX®?
There are several treatment
options for DMEYour doctor will determine which is mostappropriate for you and your DME. These
options include:• Laser treatment• Injections into the eye– One type is an anti-inflammatoryinjection, like OZURDEX®
(dexamethasone intravitreal implant)

IMPORTANT SAFETY INFORMATION (continued)
When Not to Use OZURDEX® (dexamethasoneintravitreal implant) (continued)
OZURDEX® should not be used if you have glaucoma thathas progressed to a cup-to-disc ratio of greater than 0.8.
OZURDEX® should not be used if you have a posteriorlens capsule that is torn or ruptured.

OZURDEX® is a tiny implant that
releases an anti-inflammatory agent (acorticosteroid) called dexamethasone
and is approved by the U.S. Food andDrug Administration (FDA) to treat adults
with DME. It is injected into the back ofthe eye, with minimal absorption into yourbody, and can last up to 6 months. Your
doctor will decide when and if a reinjectionof OZURDEX® is needed.
OZURDEX®
IMPLANT SIZECOMPARISONIMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions
Injections into the vitreous in the eye, including thosewith OZURDEX® (dexamethasone intravitreal implant),
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
on pages 12-19.

OZURDEX® should not be used if you are allergic
to any of its ingredients.
1011

HOW WILL OZURDEX®
(dexamethasone intravitreal implant)

WORK INSIDE MY EYE?
OZURDEX® will be injected into thevitreous cavity in the back of your eye.

A scan of aretina withDMESWOLLEN MACULAOZURDEX® treatment• Can help reduce inflammation
in your retina and swelling inthe macula
The implant dissolves• Medication is slowly released overtime as OZURDEX® dissolves• In two 3-year clinical trials, 328 people
received OZURDEX® about every
6 months, based on their doctor’s
discretion, and 328 people received sham(control) treatment• At the end of the 3-year studies, 20% (1 in5) of OZURDEX® treated people gained≥ 15 letters (3 or more lines) of vision onan eye chart compared to 11% (1 in 10) ofcontrol-treated people• Your own individual results may vary;
talk to your doctor
12AftertreatmentwithOZURDEX®
DECREASED SWELLING
OF THE MACULAIMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions (continued)
Use of corticosteroids including OZURDEX®
(dexamethasone intravitreal implant) may produce
posterior subcapsular cataracts, increased eye pressure,glaucoma, and may increase the establishment ofsecondary eye infections due to bacteria, fungi, orviruses. Let your doctor know if you have a historyof ocular herpes simplex as corticosteroids are notrecommended in these patients.
Please see additional Important Safety Information
on pages 14-19.

13

WHAT CAN I EXPECT WITH THE
OZURDEX® (dexamethasone intravitreal implant)
PROCEDURE?
BEFOREAFTER• Speak with your doctor about anyquestions/concerns you may have• Arrange to have somebody take you to
and from your appointment• Create a list of all the prescription andover-the-counter medications you take

• Your doctor will check your eye, andthen you will be ready to go home
• Over time, you should notice an
improvement in your vision. Your
individual results may vary• If your eye becomes red, sensitive tolight, painful, or develops a change invision, please contact your eye doctor
immediately

DURING• 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® using
a special applicator that’s about the sizeof a pen• During the injection you may feel pressure
on the eye• You may then hear a click when yourdoctor presses the button that releases
the OZURDEX® implant into your eye

14

Be sure to follow your doctor’s
instructions following the procedure.
IMPORTANT SAFETY INFORMATION (continued)
Common Side Effects in Diabetic Macular Edema
The most common side effects reported in patients
include: cataract, increased eye pressure, conjunctival
blood spot, reduced vision, inflammation of theconjunctiva, specks that float in the field of vision,
swelling of the conjunctiva, dry eye, vitreousdetachment, vitreous opacities, retinal aneurysm, foreign
body sensation, corneal erosion, inflammation of thecornea, anterior chamber inflammation, retinal tear,drooping eyelid, high blood pressure, and bronchitis.
Please see additional Important Safety
Information on pages 16-19.

15

WHAT SIDE EFFECTS CAN
HAPPEN WITH OZURDEX®
(dexamethasone intravitreal implant)?
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 a procedure
to remove the cataract and restore
your vision– Ask your doctor about cataractsurgery. About 3.8 million surgeries
are performed in the United States
every year• In clinical trials, after 1 injection, cataracts
developed in about 10% (24 of 243) ofOZURDEX® patients with natural lenses
and 8% (18 of 230) of sham (control)–treated patients with natural lenses• After up to a maximum of 7 treatments
over 3 years, cataracts occurred in 68%(166 of 243) of OZURDEX® treatedpatients with natural lenses and 21%(49 of 230) of sham (control)–treatedpatients with natural lenses

IMPORTANT SAFETY INFORMATION (continued)
Patient Counseling Information
After repeated injections with OZURDEX® (dexamethasone
intravitreal impant), 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® thatwill need to be managed with eye drops, and rarely,with surgery.

• 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 very rare cases, the increase in eye
pressure may require surgery. In mostcases, the prescription eye drops willtake care of the increased pressure

Please see additional Important Safety Information
on page 19.

1617

WHAT PATIENT ASSISTANCERESOURCES ARE AVAILABLE?
HOW CAN I SAVE ONOZURDEX® (dexamethasone
intravitreal implant)
TREATMENT?
Allergan® is committed to helping patientsgain access to and afford treatments. Thereare cost-savings opportunities available
for OZURDEX®.

WILL MY INSURANCE COVER
OZURDEX®?
Ask your doctor’s office to verify coveragethrough your specific insurance carrier.

If you have commercial insurance andmeet other eligibility requirements, youcan 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)
Patient Counseling Information (continued)
In the days following injection with OZURDEX®
(dexamethasone intravitreal impant), you may be at riskfor 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 invision, you should seek immediate care from your eye
doctor. You may experience temporary visual blurring
after receiving an injection and should 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

1819

LEARN MORE ABOUT OZURDEX®
AND DME AT OZURDEX.COM

Please see Important Safety Informationthroughout.
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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