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Fluocinolone Acetonide Intravitreal Implant (Iluvien®)

In Diabetic Macular Oedema

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Abstract

Fluocinolone acetonide intravitreal implant (Iluvien®) is an injectable, non-erodible, corticosteroid implant that is approved in several European countries for the treatment of chronic diabetic macular oedema (DMO). In analyses of two multinational trials in patients with DMO previously treated with macular laser photocoagulation, fluocinolone acetonide intravitreal implant 0.2 μg/day was significantly more efficacious than sham injection in improving visual acuity. At 24 months post injection, 29 % of fluocinolone acetonide intravitreal implant 0.2 μg/day recipients had an improvement in the best-corrected visual acuity (BCVA) letter score of ≥15 compared with 16 % in the sham injection group (p = 0.002) [primary endpoint]. Treatment benefit was most evident in the subgroup of patients whose duration of DMO was ≥3 years. In this subgroup at 36 months, 34 % of fluocinolone acetonide intravitreal implant 0.2 μg/day recipients had an increase in the BCVA score of ≥15, compared with 13 % of sham injection recipients (p < 0.001). Fluocinolone acetonide intravitreal implant recipients also had generally greater benefits than sham injection recipients on secondary endpoints. In patients who were phakic in the study eye at baseline, cataracts occurred in 82 % of fluocinolone acetonide intravitreal implant 0.2 μg/day recipients and 51 % of sham injection recipients. Overall, 37 % and 12 % of patients in the fluocinolone acetonide intravitreal implant and sham injection groups developed raised intraocular pressure (IOP), which was generally controlled with IOP-lowering drugs.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer was offered an opportunity to comment on this article. Changes resulting from any comments received were made by the author on the basis of scientific and editorial merit.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Mark Sanford

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  1. Mark Sanford
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Correspondence to Mark Sanford.

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The manuscript was reviewed by: R.G. Fiscella, Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, IL, USA; T.L. Levien, Pharmacotherapy Department, Washington State University Spokane, Spokane, WA, USA; J.A. Micieli, Department of Ophthalmology and Vision Science, University of Toronto, Toronto, ON, Canada.

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Sanford, M. Fluocinolone Acetonide Intravitreal Implant (Iluvien®). Drugs 73, 187–193 (2013). https://doi.org/10.1007/s40265-013-0010-x

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  • DOI: https://doi.org/10.1007/s40265-013-0010-x

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