Worldwide, 21 million people have diabetic macular edema (DME), the major cause of vision loss in people with diabetic retinopathy (DR). Symptoms can include double or blurred vision, floaters, and decreased vision.
Jessica Salazar, a 38-year-old teacher from Edinburg, Texas, was diagnosed with Type 2 diabetes at age 18. She started losing her vision when she was 28. While teaching at a private school, she began having trouble reading numbers, so she consulted her doctor. Her eye doctor, Dr. Victor Gonzalez, a retina specialist at Valley Retina Institute, diagnosed her with Diabetic Macular Edema (DME).
“It affected my job, affected my social life because now I’m dependent on people driving me around,” says Salazar. She also had to make her home an open space because she worried about falling during the night due to blurry vision.
Like many people with diabetes, Salazar must schedule time every week to see her doctors. For the past two and a half years, Salazar has had kidney failure and has been on dialysis three times a week. In addition to DME, she suffers from low blood pressure, anemia, arthritis, nerve damage, and carpal tunnel.
About DME
The retina, located at the back of the eye, is a thin layer of cells which provides our ability to see. The macula, located near the center of the retina, is responsible for central vision. In DME, fluid collects in the macula, causing swelling which leads to blurry vision and vision loss.
People with either Type 1 or Type 2 diabetes are at risk of developing Diabetic Retinopathy (DR), which can lead to DME. Left untreated, DME can cause permanent vision loss.
Those with diabetes may delay or prevent the development of DR and DME by keeping their A1C as close to normal as possible. Risk factors for developing DME include having diabetes for 10 or more years, poor control of blood sugar levels in the past, hypertension, hyperglycemia, kidney disease, or tobacco use.
Treating DME
It’s important for people with diabetes to see an eye doctor for regular eye exams. An eye doctor needs to perform an eye exam in order to diagnose DME.
There are three common treatments for DME: vascular endothelial growth factor (VEGF) inhibitor therapy which treats DME by targeting the protein, VEGF, with monthly or every-other-month treatments, corticosteroid treatment options, and laser treatments that cauterize blood vessels in the retinal tissue.
One of those corticosteroid treatments is an implant that delivers medication over a few months. In clinical trials, the effect of this corticosteroid on vision has been shown to last approximately four months and diminishes after that time.
Another treatment, the ILUVIEN microimplant, consistently and continuously delivers a very low dose of a corticosteroid called fluocinolone acetonide or FAc. The single injection provides CONTINUOUS MICRODOSING™ delivery to release the drug for up to three years. Clinical studies have shown that ILUVIEN significantly reduced the overall number of injections for DME patients.
ILUVIEN, produced by Alimera Sciences, Inc., may be an option for people who have been treated for DME with a prior course of corticosteroid without a clinically significant rise in intraocular pressure. Patients with DME should talk to their eye doctor to see if ILUVIEN is right for them.
Feeling grateful
Dr. Gonzalez prescribed ILUVIEN to treat Salazar’s DME. Now, she doesn’t have to see him as often, which is very convenient for her busy life.
Salazar’s vision is now 20/25, a huge improvement — before taking the medication, she was legally blind in one eye and partially blind in the other.
“I would recommend to any patient that suffers from DME to seek this medication — ILUVIEN — to help them reduce the edema in their eyes,” she concludes. “Our vision is the most important thing that we have, and we should not take that for granted.”
Get more information on how ILUVIEN can help treat diabetic macular edema: iluvien.com/iluvien-diabetic-macular-edema/.
This is one patient’s experience; patient results may vary.
Patient Information ILUVIEN® (ih-LOO-vee-in)
(fluocinolone acetonide intravitreal implant) 0.19 mg
This information is not comprehensive and does not take the place of talking to your doctor about your medical condition or treatment. If you have any questions about ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg, ask your doctor. Only your doctor can determine if ILUVIEN is right for you. Visit www.iluvien.com to obtain the FDA-approved product labeling.
What is ILUVIEN and what is it used for?
- ILUVIEN is a prescription medicine used to treat diabetic macular edema (DME) in patients who have been treated with corticosteroids previously and did not have a significant increase in eye pressure. DME is a swelling of the light-sen- sitive layer at the back of the eye (macula)and is a condition that may occur in people with diabetes.
- ILUVIEN is a tiny implant that is injected by your doctor into the back of the eye where it releases a continuous low dose of medicine directly to theretina for up to 36 months. The medi- cine in ILUVIEN is called fluocinolone acetonide which is a type of steroid called a corticosteroid.
- It is not known if ILUVIEN is safe and effective in children less than 18 years of age.
- Tell your doctor if the eye becomes red, sensitive to light, painful or develops a change in vision after ILUVIEN.
Who should not use ILUVIEN?
- Do not use ILUVIEN if you have or think you might have an infection in or around the eye.
- ILUVIEN should not be used if you have severe glaucoma (high pressure in the eye).
- You should not use ILUVIEN if you are allergic to any ingredients of ILUVIEN (see complete list below).
What should I tell my doctor before using ILUVIEN?
Tell your doctor if you:
- have had a history of herpes viral infection of the eye (an ulcer or sores on the eye)
- are pregnant or plan to become pregnant. It is not known if ILUVIEN can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ILUVIEN passes into your breast milk.
How should ILUVIEN be used?
- A retina specialist will insert a single ILUVIEN implant in your eye during an in-office procedure. The eye is numbed prior to the procedure, and then the implant is delivered to the back of the eye through a tiny needle within the applicator. Following ILUVIEN treatment, your doctor will schedule periodic appointments to monitor your condition.
What are some of the possible side effects of ILUVIEN?
The use of ILUVIEN may cause serious side effects including:
- serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments.
- cataracts (clouding of the lens), glaucoma and increased secondary eye infections due to bacteria, fungi, or viruses.
- the implant may move from the back of the eye to the front of the eye if the lens capsule is not intact.
- Tell your doctor if the eye becomes red, sensitive to light, painful or develops a change in vision after ILUVIEN.
The most common eye-associated (ocular) side effects reported in patients with DME who were treated with ILUVIEN include:
- cataracts. If a cataract occurs, your vision will decrease and you will need cataract surgery to restore your vision.
- increased eye pressure, which may progress to glaucoma, if untreated. For this reason, your doctor will monitor you regularly after the injection. Increase in eye pressure can be treated with eye pressure-lowering medications (usually eye drops). However, some people mayrequire eye surgery to treat their increased eye pressure.
The most common side effects not associated with the eye (non-ocular) reported in patients with DME who were treated with ILUVIEN include:
- decrease in the amount of red blood cells or hemoglobin in the blood (anemia).
- headache.
- kidney (renal) failure.
- pneumonia.
These are not all the possible side effects with ILUVIEN. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
General information about ILUVIEN
- Medicines are sometimes prescribed for purposes other than those listed in their package inserts. This is a Brief Summary of important information about ILUVIEN. Ask your doctor or pharmacist for more complete product information or visit www.ILUVIEN.com, or call 1-844-445-8843.
What are the ingredients in ILUVIEN?
- Active ingredient: 0.19 mg fluocinolone acetonide.
- Inactive ingredients: polyimide tube, polyvinyl alcohol, silicone adhesive, and water for injection.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg
Manufactured for:
Alimera Sciences, Inc. 6120 Windward Parkway
Alpharetta, GA 30005
All Rights Reserved. ILUVIEN is a registered trademark of Alimera Sciences, Inc.
Copyright ©2021 Alimera Sciences, Inc. All Rights Reserved. 1-844-445-8843. Printed in USA. US-ILV-REF-0073.