Learn more about ILUVIEN

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ILUVIEN is a CONTINUOUS MICRODOSINGTM Delivery system engineered to deliver inflammation-suppressing fluocinolone acetonide (FAc) to treat DME.1

  • Designed specifically for intraocular use.1
  • Nonbioerodable polyimide tube, the same material used in the haptics of many intraocular lenses.1
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FAc inhibits inflammatory responses to a variety of inciting agents including multiple inflammatory cytokines.1


Mechanism of Action of ILUVIEN

 

Engineered for CONTINUOUS MICRODOSINGTM Delivery

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Starting at day 1, ILUVIEN delivers a continuous submicrogram dose of FAc from a nonbioerodable polyimide implant.1,4

  • ILUVIEN contains 0.19 mg of the corticosteroid FAc, which is continuously released from a nonbioerodable, intravitreal, polyimide implant and inhibits inflammatory responses to a variety of inciting agents.1
  • The release of fluocinolone acetonide occurs in a near zero order fashion—meaning, there is minimal burst at the beginning and the level of drug released stays fairly constant.1,4
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Proven efficacy from a single implant

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ILUVIEN provided significant improvement in vision as measured by an increase of ≥ 15 letters from baseline in BCVA at 24 months.1,3

  • The safety and efficacy of ILUVIEN for the treatment of diabetic macular edema (DME) was studied vs. sham control in two 3-year pivotal trials (FAME A and FAME B).1, 3
  • 28.7% of patients treated with ILUVIEN during the FAME trials (FAME A and FAME B) saw an increase in visual acuity compared to 16.2% of sham control group patients.1,3

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Maintained Reduction in Retinal Thickness

In ILUVIEN pivotal studies, mean retinal thickness was reduced and maintained throughout the 36-month study period.4,5

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ILUVIEN was studied in patients whose DME persisted or recurred despite treatment.1,6

ILUVIEN was assessed in 2 prospective, randomized, multicenter, double-masked, parallel 3-year trials (FAME A and FAME B) of patients with DME who had previously been treated with laser photocoagulation.

  • Primary endpoint: Proportion of patients in whom vision had improved by ≥ 15 letters from baseline in best corrected visual acuity (BCVA) at 24 months.
  • Patients were treated with either ILUVIEN or sham injection (2:1).
  • All patients were allowed to receive rescue treatment for persistent edema any time after week 6 for persistent or recurrent DME, if necessary.


ILUVIEN was studied in patients whose DME persisted or recurred despite treatment1,5

  • Patients were treated with either ILUVIEN, 0.5 µg/d FAc, or sham injection (2:2:1).
  • Control patients received a sham injection.
  • Primary endpoint: Proportion of patients in whom vision had improved by ≥ 15 letters from baseline in best corrected visual acuity (BCVA) at 24 months.
  • All patients were allowed to receive rescue treatment for persistent edema any time after week 6 for persistent or recurrent DME, if necessary.
  • No patients enrolled in the phase 3 clinical trial were treatment naive. All had been treated with at least one prior macular laser treatment.
The sham injection consisted of the needle hub being pressed against the globe of the eye to simulate the injection of an implant.
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Real-world USER data supports the benefits of CONTINUOUS MICRODOSING™ Delivery

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USER STUDY
USER: U.S. Retrospective Chart Review in Patients Receiving ILUVIEN

130

PATIENTS

160

EYES

4

U.S. CLINICAL CENTERS

The USER Study provides valuable, real-world clinical insights on visual acuity (VA), edema, and safety before and after ILUVIEN implantation

  • At the time of the pivotal ILUVIEN FAME studies, there were no approved treatments for DME; therefore, outcomes in patients after prior injectable therapies could not be assessed
  • In USER, treatments used before and/or after ILUVIEN included laser, intravitreal anti-VEGF, and steroids

Limitations of the USER Study

  • Data are based on clinical practice, where the reporting of data is not standardized, and the data may not be as rigorous as in a clinical trial where the data collected are monitored
  • USER involved the collection of data up to 3 years prior to ILUVIEN (where available) and all available data post-ILUVIEN
    Mean follow-up after ILUVIEN was 403 days, with 102 eyes followed up for 6 months, 92 for 12 months, and 50 for 18 months
  • Optical coherence tomography (OCT) data were only available for 120 eyes

Regardless of VA at the time of ILUVIEN treatment, after receiving ILUVIEN patients required fewer DME treatments on average

DME treatment frequency before and after ILUVIEN treatment, entire populatione

(N = 160 eyes)
e Mean follow-up after ILUVIEN was 403 days, with 102 eyes followed up for 6 months, 92 for 12 months, and 88 for 15 months. The number of patients available for follow-up at each time point varied.
f P<0.001 vs treatment frequency before ILUVIEN.
g P=0.026 vs treatment frequency before ILUVIEN.
Please see full Prescribing Information and Important Safety Information below.
  • In the 42% of eyes that had a VA of ≥ 20/40 at the time of ILUVIEN treatment, VA was maintained with 87% fewer DME treatments on average
  • In the 20% of eyes that had a VA of < 20/100 at the time of ILUVIEN treatment, VA improved with a reduction in the number of DME treatments on average
VA
USER data confirm the benefits of CONTINUOUS MICRODOSING™ Delivery on visual acuity (VA)
OCT
USER data confirm the benefits of CONTINUOUS MICRODOSING™ Delivery on retinal edema
IOP
Real-world evidence from USER confirms that when used per label, ILUVIEN has a predictable intraocular pressure (IOP) profile

Most Common Ocular Reported Adverse Events in the ILUVIEN Phase 3 Clinical Trials1

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Ocular adverse reactions for patients in the ILUVIEN Phase 3 clinical trials were consistent with the use of ophthalmic corticosteroid treatment. 1

  • In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%, sham 50%) and intraocular pressure evaluation of ≥10 mmHg (ILUVIEN 34%, sham 10%).
  • The median time to cataract reporting in patients treated with ILUVIEN was 12 months and 19 months for patients in the sham group.1
  • The median time to cataract surgery was 15 months for both ILUVIEN and sham groups.1

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Mean IOP remained steady throughout the studies1

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Summary of ILUVIEN IOP elevation from the ILUVIEN Phase 3 clinical trials

  • 34% of patients had IOP elevation ≥ 10 mm Hg from baseline, as compared to 10% with a sham
  • 20% of patients had IOP elevation ≥ 30 mm Hg from baseline, as compared to 4% with a sham

CONTINUOUS MICRODOSINGTM Delivery for Continuous Therapy

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ILUVIEN is administered in the office setting using a specially designed applicator.

 

  • ILUVIEN is inserted into the vitreous cavity via a 25-gauge needle.
  • Each implant contains 0.19 mg fluocinolone acetonide (FAc) and is engineered to provide a submicrogram release at an initial rate of 0.25 µg/day lasting 36 months.

 

ILUVIEN is supplied in a sterile, single-use, preloaded custom applicator.

  • Packaged in a sealed tray that should be stored at room temperature between 59ºF and 86ºF.

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For more information regarding ILUVIEN administration, please refer to:

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