OZURDEX® (dexamethasone intravitreal implant) 0.7 mg is a sustained-release, biodegradable steroid implant approved by the U.S. Food and Drug Administration (FDA) to be injected into the eye (vitreous) to treat adults with:

  • Diabetic macular edema

Your doctor will discuss with you the reasons why OZURDEX® was selected as well as the benefits and risks of treatment.

How OZURDEX®
works
Study results
IMPORTANT SAFETY
INFORMATION
FAQ

OZURDEX® is a sustained-release, biodegradable implant containing the corticosteroid dexamethasone

Corticosteroids, such as dexamethasone, block chemical pathways that lead to:
  • Inflammation
  • Leakage from the retinal blood vessels
  • Swelling (edema) of the retina

OZURDEX® may help reverse some vision loss that may be caused by swelling
of the macula

OZURDEX® is the first and only injectable, biodegradable dexamethasone implant

A biodegradable implant is one that doesn’t need to be removed after it releases medication. 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.

An artist’s interpretation of an OZURDEX® implant dissolving.

Possible side effects of OZURDEX® include increased eye pressure and cataracts

Corticosteroids, such as OZURDEX® intravitreal implants, can cause the fluid pressure inside the eye to increase. This is not something you can feel. So, following the injection, your doctor should regularly monitor your eye pressure. If you experience this side effect, treatment such as medicated eyedrops or surgery may be required to lower the pressure.

In clinical trials, 68% of OZURDEX® patients with natural lenses (166 of 243) developed cataracts, compared with 21% of patients with natural lenses who received simulated injections (49 of 230). 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.

What the studies showed

In 2 clinical studies, 328 patients were treated with OZURDEX®, and another 328 patients received simulated injections. Patients were eligible to receive injections about once every 6 months, at their doctor’s discretion, for 3 years. At the end of the studies:
  • 20% (1 in 5) of those who received OZURDEX® gained 3 or more lines of vision on the eye chart
  • In comparison, 11% (about 1 in 10) of patients who received simulated injections had similar gains

After an injection, vision improvements peaked at about 3 months and then lowered. Patients received additional injections throughout the studies to continue vision improvement.

For some patients in the studies, vision decreased. Talk to your doctor to learn more about how this may apply to you. It’s important to remember that each case of DME is unique. Your own results may vary.

OZURDEX® approved use and Important Safety Information

Approved Use
OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used:
  • To treat adults with diabetic macular edema

IMPORTANT SAFETY INFORMATION
OZURDEX® should not be used if you have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.

OZURDEX® should not be used if you have glaucoma.

OZURDEX® should not be used if you have a posterior lens capsule that is torn or ruptured.

You should not use OZURDEX® if you are allergic to any of its ingredients.

Injections 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 may monitor you regularly after the injection.

Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex.

The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, high blood pressure and bronchitis.

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.

In the days following injection with OZURDEX®, you may be at risk 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 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here for full Prescribing Information.

Frequently asked questions

Below you’ll find answers to frequently asked questions about biodegradable implants, intravitreal injections, OZURDEX®, and safety.

Click any of the questions below to learn more:

General
What is a biodegradable implant?
Are intravitreal injections common?
How does the OZURDEX® intravitreal implant work?
How is OZURDEX® administered?
What happens during the injection procedure?
Will I receive OZURDEX® more than once?
Is there anyone who should not be given OZURDEX®?
Are there any risks with intravitreal injections?
What else should I know about OZURDEX®, eye pressure, and cataracts?

Diabetic Macular Edema (DME)
Why did my doctor choose OZURDEX®?
What results can I expect with an OZURDEX® intravitreal implant?

General

What is a biodegradable implant?
A biodegradable implant is one that doesn’t need to be removed after it releases medication. 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 diabetic macular edema (DME).

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.

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. As the injection occurs, you may feel some pressure. You may then hear a click when your doctor presses the button that releases the OZURDEX® implant in your eye.

Will I receive OZURDEX® more than once?
The OZURDEX® implant slowly dissolves, releasing medication. As the level of medication decreases over time, swelling or inflammation may affect your vision again. If this occurs, your doctor may recommend another OZURDEX® injection.

Is there anyone who should not be given OZURDEX®?
You should not receive OZURDEX® if:
  • You have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva including active herpes viral infections of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases
  • You have glaucoma
  • You have a posterior lens capsule that is torn or ruptured
  • You are allergic to any ingredient of OZURDEX® intravitreal implants

Are there any risks with intravitreal injections?
Injections into the vitreous in the eye, including those with OZURDEX®, are associated with serious eye infection (endophthalmitis, pronounced en-dof-thal-my-tis), eye inflammation, increased eye pressure, and retinal detachments. Your eye doctor may monitor you regularly after the injection.

Use of corticosteroids may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex.

The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, high blood pressure, and bronchitis.

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.

In the days following injection with OZURDEX®, you may be at risk 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 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.

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 OZURDEX®, eye pressure, and cataracts?
Corticosteroids, such as OZURDEX® intravitreal implants, can cause the fluid pressure inside the eye 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.

In clinical trials, 68% of OZURDEX® patients with natural lenses (166 of 243) developed cataracts, compared with 21% of patients with natural lenses who received simulated injections (49 of 230). 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.

Why did my doctor choose OZURDEX®?
OZURDEX® has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with diabetic macular edema. 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 diabetic macular edema is unique. Your own results may vary.

Who should not receive OZURDEX®?

You should not receive OZURDEX® if:
  • You have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases
  • You have glaucoma
  • You have a posterior lens capsule that is torn or ruptured
  • You are allergic to any ingredient of OZURDEX® intravitreal implants
*
RVO - swelling of the macula following branch or central retinal vein occlusion

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 of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases. See more below

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 of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.

OZURDEX® should not be used if you have glaucoma that has progressed to a cup-to-disc ratio of greater than 0.8.

OZURDEX® should not be used if you have a posterior lens capsule that is torn or ruptured.

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

Warnings and Precautions
Injections 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.

Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex as corticosteroids are not recommended in these patients.
See more below

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 of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.

OZURDEX® should not be used if you have glaucoma that has progressed to a cup-to-disc ratio of greater than 0.8.

OZURDEX® should not be used if you have a posterior lens capsule that is torn or ruptured.

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

Warnings and Precautions
Injections 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.

Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex as corticosteroids are not recommended in these patients.

Common Side Effects in Diabetic Macular Edema
The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, high blood pressure, and bronchitis.

Common Side Effects in Retinal Vein Occlusion and Uveitis
The most common side effects reported in patients for retinal vein occlusion and uveitis include: increased eye pressure, conjunctival blood spot, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache.
See more below

Approved Uses
OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used:
  • To treat adults with diabetic macular edema
  • To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
  • To treat adults with noninfectious inflammation of the uvea (uveitis) affecting the back segment of the eye
IMPORTANT SAFETY INFORMATION (continued)
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.

In the days following injection with OZURDEX®, you may be at risk 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 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 click here for full Prescribing Information.