Below is a list of FAQs about biodegradable implants, intravitreal injections, OZURDEX
General
What is a biodegradable implant?
A biodegradable implant is one that doesn’t need to be removed after it’s done working.
OZURDEX
® biodegradable implants use advanced NOVADUR
®
drug delivery technology, in which biodegradable material is combined with the active
drug dexamethasone to form a tiny rod-shaped implant. Inside the eye, the implant
is slowly dissolved by the vitreous gel that fills the eye, releasing dexamethasone.
OZURDEX
® is an implant injected into the eye (vitreous) to treat
adults with macular edema following branch retinal vein occlusion (BRVO) or central
retinal vein occlusion (CRVO) and to treat adults with noninfectious uveitis affecting the posterior segment of the eye.
Are intravitreal injections common?
Yes. Intravitreal injections are now used to deliver medication to treat many types
of eye conditions. Your Retina Specialist is specially trained in giving eye injections.
How does the OZURDEX® intravitreal implant work?
OZURDEX
® is a biodegradable implant containing the corticosteroid
dexamethasone. Corticosteroids, such as dexamethasone, block chemical pathways that
lead to inflammation, leakage from the retinal blood vessels, and edema. OZURDEX
®
may help reverse some vision loss that may be caused by a retinal vein occlusion or noninfectious posterior segment uveitis.
How is OZURDEX® administered?
The OZURDEX
® implant is so tiny that it can be injected into the
eye (vitreous) with a procedure in your doctor’s office. Each implant is already inside a special
applicator device that is needed to perform the insertion. The implant will be injected
into the vitreous humor inside your eye. This is known as an intravitreal injection.
What happens during the injection procedure?
You will be awake during the procedure. Your doctor will follow steps that include
ensuring the surface of the eye is clean and numbing the surface of the eye to help
keep you comfortable. OZURDEX
® is injected using a special applicator
device that’s about the size of a pen. The applicator is designed to help your doctor
deliver OZURDEX
® to the vitreous where the medication is needed.
The injection will be complete within seconds, and the procedure is generally well
tolerated by patients.
Will I receive OZURDEX® more than once?
Your doctor may decide to administer OZURDEX
® again if he or she
believes that you may benefit from another injection.
Is there anyone who should not be given OZURDEX®?
You should not receive OZURDEX
® if you have an eye infection in or
near your eye (including herpes viral infection of the eye; vaccinia; varicella;
mycobacterial infections; and fungal diseases); if you have advanced glaucoma; or
if you are allergic to corticosteroids or to any other ingredient of OZURDEX
®
intravitreal implants.
Are there any risks with intravitreal injections?
Injections into the vitreous in the eye are associated with serious eye infection
(endophthalmitis, pronounced
en-dof-thal-my-tis), eye inflammation,
increased eye pressure, and retinal detachments. In the days following an injection
with OZURDEX
®, patients are at risk for serious eye infection or
elevated eye pressure.
If your eye becomes red, sensitive to light, painful, or develops
a change in vision, you should seek immediate care from your eye doctor.
Also, you may experience temporary visual blurring after receiving an injection
and should not drive or use machines until this has resolved. These are not the
only risks associated with intravitreal injections. If you experience other side
effects, you should immediately contact your eye doctor. Your Retina Specialist
will discuss the possible risks with you before performing the injection.
What else should I know about safety and follow-up?
Corticosteroids, such as OZURDEX
® intravitreal implants, can cause
the fluid pressure inside the eye (intraocular pressure) to increase. This is not
something you can feel. So, following the injection, your doctor should monitor
your eye pressure. If you experience this side effect, treatment such as medicated
eyedrops or surgery may be required to lower the pressure.
Some patients who receive OZURDEX
® intravitreal implants may develop
cataracts or their existing cataracts may worsen. These are not the only risks associated
with intravitreal injections. If you experience other side effects, you should immediately
contact your eye doctor. It’s important to remember that not treating macular edema
may lead to irreversible vision loss. You should discuss this issue with your doctor.
Retinal Vein Occlusion
Why did my doctor choose OZURDEX®?
OZURDEX
® has been approved by the US Food and Drug Administration
(FDA) to treat macular edema following branch or central retinal vein occlusion.
OZURDEX
® has been proven effective in large clinical trials. Your doctor will discuss
with you the reasons why OZURDEX
® was selected as well as the benefits
and risks of treatment.
What results can I expect with an OZURDEX® intravitreal implant?
It’s important to remember that each case of retinal vein occlusion is unique. In
clinical studies, 20% (20 of 100) to 30% of patients (30 of 100) who received OZURDEX
®
gained 3 or more lines of vision on the eye chart within 1 to 2 months—compared
with 7% (7 of 100) to 12% of patients (12 of 100) who received sham (simulated)
injections. Once vision had improved, the improvement lasted approximately 1 to
3 months. Your own results may vary.
Noninfectious Posterior Segment Uveitis
Why did my doctor choose OZURDEX®?
OZURDEX
® has been approved by the US Food and Drug Administration
(FDA) to treat noninfectious uveitis affecting the posterior segment of the eye.
OZURDEX
® intravitreal implant has been proven effective in a large
clinical trial. Your doctor will discuss with you the reasons why OZURDEX
® was selected as well as the benefits and risks
of treatment.
What results can I expect with an OZURDEX® intravitreal implant?
In a clinical study, 46.8% of OZURDEX
® patients (about 47 of 100) achieved a vitreous haze score of zero, that is, no detectable haze, at week 8—compared with 11.8% of patients (about 12 of 100) who received sham (simulated) injections. Also, at week 8, 42.9% of OZURDEX
® patients (about 43 of 100) gained 3 or more lines of vision on the eye chart, compared with 6.6% of sham-treated patients (about 7 of 100).
It’s important to remember that each case of uveitis is unique. Your own results may vary.
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