for immediate release now prescribing iluvien implant) … · (fluocinolone acetonide intravitreal...

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1 FOR IMMEDIATE RELEASE For Press Inquiries: Now Prescribing ILUVIEN ® (fluocinolone acetonide intravitreal implant) 0.19 mg for Diabetic Macular Edema (DME) , , , a ophthalmic practice based in , today announced that it is now prescribing ILUVIEN® for select patients diagnosed with diabetic macular edema who have been previously treated with a course of corticosteroids and did not have a significant increase in eye pressure. ILUVIEN is a tiny intraocular implant that continuously releases a low dose of an anti-inflammatory medication called fluocinolone acetonide (FAc) to the retina for up to 36 months with a single injection. ILUVIEN helps reduce the inflammation and edema associated with DME. ILUVIEN is the only prescription medication option for DME that can deliver continuous treatment for up to 36 months with a single injection. The most common risks associated with ILUVIEN treatment are the formation of cataracts and increased intraocular pressure. “We are proud to offer appropriate patients this treatment option for DME,” commented . “Treating via a long-term, sustained release implant can alleviate significant treatment burdens for patients who might otherwise struggle with frequent office visits and eye injections. We encourage patients living with DME to reach out to our practice for a consultation, so we can develop a personalized treatment strategy, which may include the use of ILUVIEN and the potential for maintaining vision longer, with fewer injections.” About For more information or to set up a consultation, please visit About Diabetic Macular Edema (DME) DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient

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Page 1: FOR IMMEDIATE RELEASE Now Prescribing ILUVIEN implant) … · (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME)

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FOR IMMEDIATE RELEASE

For Press Inquiries:

Now Prescribing ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg for Diabetic Macular Edema (DME)

, , – , a ophthalmic practice based in , today announced that it is now prescribing ILUVIEN® for select patients

diagnosed with diabetic macular edema who have been previously treated with a course of corticosteroids and did not have a significant increase in eye pressure. ILUVIEN is a tiny intraocular implant that continuously releases a low dose of an anti-inflammatory

medication called fluocinolone acetonide (FAc) to the retina for up to 36 months with a single

injection. ILUVIEN helps reduce the inflammation and edema associated with DME.

ILUVIEN is the only prescription medication option for DME that can deliver continuous treatment for up to 36 months with a single injection. The most common risks associated with ILUVIEN treatment are the formation of cataracts and increased intraocular pressure.

“We are proud to offer appropriate patients this treatment option for DME,” commented

. “Treating via a long-term, sustained release implant can alleviate

significant treatment burdens for patients who might otherwise struggle with frequent office visits and eye injections. We encourage patients living with DME to reach out to our practice for a consultation, so we can develop a personalized treatment strategy, which may include the use of ILUVIEN and the potential for maintaining vision longer, with fewer injections.”

About

For more information or to set up a consultation, please visit

About Diabetic Macular Edema (DME) DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood

vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient

Page 2: FOR IMMEDIATE RELEASE Now Prescribing ILUVIEN implant) … · (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME)

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until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision.

Indication: ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Important Safety Information 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 advanced glaucoma. You should not use ILUVIEN if you are allergic to any ingredients of ILUVIEN. Injections into the vitreous in the eye are associated with a serious eye infection

(endophthalmitis), eye inflammation, increased eye pressure, glaucoma, andretinal detachments. Your eye doctor should monitor you regularly after theinjection.

Use of corticosteroids including ILUVIEN may produce cataracts (ILUVIEN 82%;sham 50%), increased eye pressure (ILUVIEN 34%; sham 10%), glaucoma, andmay increase secondary eye infections due to bacteria, fungi, or viruses. Let yourdoctor know if you have a history of herpes viral infections of the eye.

If the posterior capsule of the lens of your eye is missing or torn the ILUVIENimplant may move to the front chamber of the eye.

The most common side effects reported in patients with diabetic macular edemawho were treated with ILUVIEN include cataracts (ILUVIEN 82%; sham 50%) andincreased eye pressure (ILUVIEN 34%; sham 10%).

Prescribing Information available at: https://hcp.iluvien.com/wp-content/uploads/2018/08/Prescribing-Information.pdf

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.

About ILUVIEN

Approved by the FDA in 2014, ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSINGTM technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of edema associated with diabetic macular edema (DME), enabling many patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., to treat DME in patients who have been previously treated with a course of corticosteroids and did not

have a clinically significant rise in intraocular pressure.

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See www.ILUVIEN.com for more information, including important safety information.

ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg Manufactured for: Alimera Sciences, Inc. 6120 Windward Parkway Alpharetta, GA 30005 See: www.alimerasciences.com ILUVIEN is a registered trademark of Alimera Sciences, Inc. Copyright © 2019 Alimera Sciences, Inc. All rights reserved. 1-844-445-8843. US-ILV-MMM-0749 09/2019