July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Efficacy and Safety of Fluocinolone acetonide (FAc) implant (ILUVIEN) for treating Diabetic Macular Edema (DME) - A 3-year U.S. Retrospective, multi-center Audit
Author Affiliations & Notes
  • Robert Wang
    Retina/Uveitis, Texas Retina Associates, Dallas, Texas, United States
    Ophthalmology, UT Southwestern, Dallas, Texas, United States
  • Footnotes
    Commercial Relationships   Robert Wang, Alimera Sciences (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2639. doi:
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      Robert Wang; Efficacy and Safety of Fluocinolone acetonide (FAc) implant (ILUVIEN) for treating Diabetic Macular Edema (DME) - A 3-year U.S. Retrospective, multi-center Audit. Invest. Ophthalmol. Vis. Sci. 2019;60(9):2639.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : ILUVIEN is a sustained-release 0.19 mg FAc intravitreal implant approved in the US for the treatment of DME treated with a course of prior corticosteroids without a clinically significant intraocular pressure response. There is no 3-year data from the US to date and we tested the hypothesis that ILUVIEN would last for up to 3 years as indicated in the US label.

Methods : A US retrospective, multi-center (n=7), real-world study involving 27 patients (41 eyes) with DME and treated with the FAc implant for 34 months (range, 22-41 months). Efficacy was based on treatment burden and changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Safety was also assessed in terms of intraocular pressure (IOP) management.

Results : The most widely used DME treatment prior to FAc implant was combination therapy of anti-VEGF and steroid (43.9%) followed by steroid (31.7%). Following FAc implant the treatment burden was 1 treatment every 2.75 months and reduced to 1 treatment every 8.1 months after FAc implant was administered (p<0.001). 43% of the eyes required no additional treatment and those that did were primarily treated with intravitreal injections of bevacizumab. Eyes with BCVA of <65 ETDRS letters at baseline gained 11.3 letters by year 3 and eyes with BCVA ≥65 ETDRS letters maintaining good vision up to year 3. There was a steady decline in CRT from 396 µm at baseline to 341 µm, 304 µm and 338 µm at years 1, 2 and 3, respectively. At baseline only 25% of the eyes had a CRT <300 µm and this increased to a maximum of 77% of eyes achieving this at month 21. In terms of safety, IOP remained below 21 mmHg throughout and increases in IOP were all controlled using IOP-lowering drops

Conclusions : The study provides the first 3-year real-world evidence from the US and findings support the hypothesis that in real-world practices, FAc implant lasts for up to 3 years. Data also shows that in DME patients with persistent or recurrent DME, the FAc implant helps to reduce treatment frequency over a 3 year period as well as improving anatomical and functional outcomes. The drug safety profile was consistent with data available from clinical trials and real-world evidence.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

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