A healthy retina is essential for normal vision. DME may damage the retina and lead to impaired vision or loss of vision.

How healthy
eyes work
What is DME?
Symptoms of DME
Effects of diabetic
eye disease

How the eye works

Light crosses the cornea, then passes through the opening in the iris (the pupil) to the lens, which focuses the light on the retina—the inner lining of the back of the eye.

The retina’s role
The retina is lined with light-sensitive cells (photoreceptors) called rods and cones. The macula is the center of the retina, and it is responsible for sharp central vision. The fovea is a small depression in the macula that provides the sharpest vision of all.

When light reaches the retina, the photoreceptors send impulses along the optic nerve to the brain, which interprets them as vision.



Diabetic macular edema

Diabetic eye disease (retinopathy) can damage the small blood vessels of the eye. Fluid leaking from these blood vessels may cause the central part of the retina (the macula) to swell. This is called diabetic macular edema (DME). Macular edema is the most common cause of vision loss in people who have diabetes.

Photograph of a retina with diabetic macular edema
The dark central area shows edema and bleeding.

Image provided by Phototake. Barbara Galati –
Ophthalmologist/Photographer.

Symptoms of DME

If your doctor finds DME early, you may not have any symptoms. If DME worsens, it can lead to blurry central vision. The blurriness can range from mild to severe. DME can cause significant vision loss over time.

Range of vision impairment due to DME

Mild blurry vision

Moderate blurry vision

Severe blurry vision

Swelling of the macula and other effects of DME

Diabetes is a problem with how your body uses sugars (glucose), leading to high blood sugar levels. Over time, high blood sugar can damage the small blood vessels in the eye (capillaries), which can lead to inflammation. Fluid leaking from these blood vessels may cause the central part of the retina (the macula) to swell, and this is called diabetic macular edema (DME).

DME can lead to permanent vision problems.

OZURDEX® (dexamethasone intravitreal implant) is an FDA-approved drug treatment for diabetic macular edema.

*
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)
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.

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.