OSLI Retina

August 2019

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ILUVIEN ® with CONTINUOUS MICRODOSING ™ Delivery is specifi cally engineered for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically signifi cant rise in intraocular pressure. In pivotal studies, ILUVIEN demonstrated e‚ cacy in visual acuity through 24 months (primary endpoint), which was sustained for up to 36 months. 1,2,3 Adverse reactions in the ILUVIEN Phase 3 clinical trials were consistent with other corticosteroid treatments. 1 INDICATION ILUVIEN ® (fl uocinolone 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 signifi cant rise in intraocular pressure. IMPORTANT SAFETY INFORMATION Contraindications • ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. • ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8. • ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product. Warnings and Precautions • Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye infl ammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the intravitreal injection. • Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection. • Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber. Adverse Reactions • In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of ≥10 mm Hg (ILUVIEN 34%; sham 10%). Please see Brief Summary of Full Prescribing Information on the following page. 1. Iluvien [package insert]. Alpharetta, GA: Alimera Sciences, Inc.; 2. Campochiaro PA, Brown DM, Pearson A, et al. Long- term benefi t of sustained delivery fl uocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118(4):626-635.e2. 3. Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery fl uocinolone acetonide vitreous inserts provide benefi t for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125-2132. CONTINUOUS MICRODOSING is a trademark of Alimera Sciences, Inc. Copyright © 2019 Alimera Sciences, Inc. All rights reserved. ILUVIEN is a registered trademark of Alimera Sciences, Inc. 1-844-445-8843. Printed in USA. US-ILV-MMM-0652. 05/2019 6120 Windward Parkway Alpharetta, GA 30005 www.alimerasciences.com Learn more at HCP.ILUVIEN.com Consider CONTINUOUS MICRODOSING TM Delivery with ILUVIEN ® for consistent, continuous treatment of persistent diabetic macular edema (DME)

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