ILUVIEN 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.
In the FAME Study, it was noted that none of the patients who had a prior history of steroid treatment required surgical intervention for IOP. This led to the steroid challenge being added to the ILUVIEN indication. Real-world data supports that the manageable IOP response noted in the prior steroid challenge has a greater than 96% predictive value for the manageable IOP response that may be seen with ILUVIEN.1,2
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
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Tel: 1-844-445-8843, Option 3
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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.