The clinical studies of ILUVIEN demonstrate the product’s effectiveness, safety and durability in IOP predictability, vision improvement, and the reduction in treatment burden and retinal thickness variability.
In the ILUVIEN Phase 3 clinical trials (FAME), there was a sustained improvement in visual acuity (VA) and reduction in retinal edema for up to 3 years, indicating treatment durability.
ILUVIEN was evaluated in 2 prospective, randomized, multicenter, double-masked, parallel 3-year clinical trials (FAME A and FAME B).
ILUVIEN was studied in patients whose diabetic macular edema (DME) persisted or recurred despite treatment.
The ILUVIEN Phase 3 clinical trials assessed patients with DME who had previously been treated with laser photocoagulation.
Patients were treated with either ILUVIEN or sham injection (2:1).
All patients were allowed to receive rescue laser any time after week 6 for persistent edema or recurrent DME, if necessary, and an additional implant after month 12.
FAME study data: Impact of prior ophthalmic corticosteroid injection on IOP-lowering surgery2
*For a minimum of 7 days
The FDA indication differs from the FAME study inclusion criteria due to the requirement for “a prior course of corticosteroid without a clinically significant rise in IOP.” Seventy-two patients in the pivotal ILUVIEN FAME studies previously had an ophthalmic steroid injection and did not fall into the exclusion criteria “patients with a history of uncontrolled IOP elevation with steroid use that did not respond to topical therapy.”2
The USER Study provides valuable, real-world clinical insights on visual acuity (VA), edema, and safety before and after ILUVIEN implantation. When used per label, ILUVIEN has a predictable IOP profile following a steroid challenge.
Results confirm the safety and efficacy profile of ILUVIEN. ILUVIEN significantly reduced treatment burden without significantly increasing the risk of steroid-induced pressure elevation.
USER was a retrospective study of 160 eyes in 130 patients receiving ILUVIEN.
IOP-related events before and after ILUVIEN, entire population
(N=160 eyes).
Patients who had an IOP response of ≤ 25 mmHg associated with a prior steroid treatment were 94% to 98% likely to have an IOP response ≤ 25 mmHg associated with ILUVIEN.
A 94% predictive value is calculated using the maximum IOP measured on ILUVIEN and a 98% predictive value is calculated using the last measured IOP value on ILUVIEN.
The three-year, phase IV, real-world observational PALADIN study evaluated the long-term safety of ILUVIEN for patients with DME. This study data supports the benefit of using a prior course of corticosteroid to mitigate the risk of uncontrolled IOP elevations. The study also reported secondary outcomes of vision improvement and reduction in treatment burden and retinal thickness variability.
There were a total of 202 eyes of 159 patients enrolled in the study. The mean follow-up length for these eyes was 27.6 months and 94 eyes completed 36 months of follow-up.
IOP increases that occurred were considered manageable with standard treatments.
IOP increases of > 30 mmHg occurred in 10.9% of eyes.
30.19% of eyes required IOP-lowering medication.5
Incisional IOP-lowering surgical rate for all eyes was 3.96% with 2.47% due to steroid use and 1.49% due to neovascular glaucoma.5 This compares favorable to the 4.8% seen in the pivotal FAME Studies.
IOP response ≤ 25 mmHg after the steroid challenge predicted a similar outcome after ILUVIEN treatment at the final visit in 97% of eyes.
At 36 months, eyes experienced a mean 3.6 letter increase in BCVA. Prior to ILUVIEN, eyes experienced a mean change of -8.4 letters despite most patients having received prior DME treatment.6
Eyes with a good starting vision (20/40 or better) were able to maintain their good vision. Eyes with a baseline BCVA of worse than 20/40 were able to significantly improve their vision (mean +6.5 letters, p=0.0069).
BCVA gains were significant at most time points throughout the study.
In the up-to-3-year period prior to ILUVIEN, study eyes received a median of 3.4 treatments per year. During the 3-year follow-up period with the ILUVIEN implant in place, the median treatment frequency declined to just 1 supplemental treatment per year. This represents a 70.5% reduction in median yearly treatment burden for patients.
Among eyes that completed 36 months of the study, 25% of eyes did not require any supplemental treatments during the study.
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
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1-844-445-8843. US-ILV-MMM-0538
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:
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.
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.