ILUVIEN is a corticosteroid implant injection for diabetic macular edema (DME). ILUVIEN delivers a consistent, continuous microdose of FAc (fluocinolone acetonide) to the retinal tissue for efficient and effective treatment of DME for up to 36 months.1,2 In DME, inflammation affecting the retina is chronic and the desired therapeutic effect is long-term suppression or resolution of that inflammation and the associated edema. An ideal steroid is one that can durably provide therapeutic effects with a low dose directly to the target retinal tissue.3
Corticosteroids inhibit inflammatory responses to a variety of inciting agents, including multiple inflammatory cytokines. Therefore, corticosteroids reduce edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.6,7,8
Beginning on day 1, ILUVIEN delivers a continuous therapeutic submicrogram dose of inflammation-suppressing FAc for up to 36 months. A longer-term treatment may reduce the number of injections for appropriate patients with DME.9
Aqueous levels of FAc after injecting ILUVIEN in human eyes (n=12).
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.
CONTRAINDICATIONS
Contraindications
Warnings and Precautions
Adverse Reactions
Please see full Prescribing Information.
Tel: 1-844-445-8843, Option 3
Summary Overview of AccessPlus
This site is intended for US residents only. ILUVIEN is a registered trademark of Alimera Sciences, Inc.
CONTINUOUS MICRODOSING and the CONTINUOUS MICRODOSING symbol are trademarks of Alimera Sciences, Inc.
1-844-445-8843. US-ILV-MMM-0538
Consider ILUVIEN for phakic patients with DME, particularly those aged > 50 years and/or with developing cataracts
Patients with diabetes are 2 to 5 times more prone to cataract development2
In the ILUVIEN Phase 3 clinical trials:
Observations from a small, real-world cohort of vitrectomized patients with DME treated with ILUVIEN
Authors of this study received compensation from Alimera. Two authors received speaker honoraria from Alimera, and two authors were consultants. One author received reimbursement of travel expenses and study support from Alimera.
FAME A and B were randomized, double-masked, sham injection-controlled, parallel-group, multicenter studies conducted under a single protocol over 36 months.
Study arms:
956 subjects randomized 2:2:1
Primary endpoint:
Proportion of subjects with improvement in BCVA ≥ 15 letters at 24 months
Inclusion criteria:
Foveal thickness ≥ 250 μm despite ≥ 1 prior focal/grid macular laser photocoagulation treatment and BCVA in ETDRS letter score between 19 and 68 (20/50–20/400).
Exclusion criteria:
Glaucoma, ocular hypertension, IOP > 21 mm Hg, or using IOP-lowering drops.
References:
1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.
1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.
2. Parrish RK, Campochiaro PA, Pearson PA, Green K, Traverso CE, FAME Study Group. Characterization of intraocular pressure increases and management strategies following treatment with fluocinolone acetonide intravitreal implants in the FAME trials. Ophthalmic Surg Lasers Imaging Retina. 2016;47:426-435.
1. Meireles A, Goldsmith C, El-Ghrably I, et al. Efficacy of 0.2 µg/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy. Eye (Lond). 2017;31(5):684-690.
1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.
2. Javadi MA, Zari-Ghanavati S. Cataracts in diabetic patients: A review article. J Ophthalmic Vis Rec. 2008;3(1):52-65.
3. Data on file. Alimera Sciences, Inc.
4. Mordi JA, Ciuffreda KJ. Statis aspects of accommodation: age and presbyopia. Vision Res. 1998;38:1643-1653.
5. Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626-635.
6. Yang Y, Bailey C, Holz FG, et al. Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants. Eye (Lond). 2015;29:1173-1180.
1. Data on file. Alimera Sciences, Inc.
1. Data on file. Alimera Sciences, Inc.