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Letter to the editor: dexamethasone intravitreal implant in the treatment of diabetic macular edema

Authors Hall J, C Wright C

Received 5 August 2015

Accepted for publication 18 August 2015

Published 16 November 2015 Volume 2015:9 Pages 2119—2121

DOI https://doi.org/10.2147/OPTH.S93836

Checked for plagiarism Yes

Editor who approved publication: Dr Scott Fraser


John Hall

Alimera Sciences Ltd., Aldershot, Hampshire, UK


I read “Dexamethasone intravitreal implant in the treatment of diabetic macular edema” published July 2015 by Dugel et al.1This article is very interesting in terms of providing an outline of the role of inflammation in the pathogenesis of diabetic macular edema and explaining the value of corticosteroids in the treatment of diabetic macular edema.

However, I would like to draw your attention to the data presented for ILUVIEN® (fluocinolone acetonide; FAc) in Table 2, which has been presented incorrectly and does not reflect the approved product and dose in Europe. ILUVIEN is indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies2 and is approved in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, and the United Kingdom. ILUVIEN was launched in the United Kingdom in April 2013, Germany in May 2013, and Portugal in January 2015.3

View original paper by Dugel et al.


Dear editor

I read “Dexamethasone intravitreal implant in the treatment of diabetic macular edema” published July 2015 by Dugel et al.1 This article is very interesting in terms of providing an outline of the role of inflammation in the pathogenesis of diabetic macular edema and explaining the value of corticosteroids in the treatment of diabetic macular edema.

However, I would like to draw your attention to the data presented for ILUVIEN® (fluocinolone acetonide; FAc) in Table 2, which has been presented incorrectly and does not reflect the approved product and dose in Europe. ILUVIEN is indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies2 and is approved in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, and the United Kingdom. ILUVIEN was launched in the United Kingdom in April 2013, Germany in May 2013, and Portugal in January 2015.3

Abbreviations: DME, diabetic macular edema; BCVA, best-corrected visual acuity; FAME, Fluocinolone Acetonide for Diabetic Macular Edema; ETDRS, Early Treatment Diabetic Retinopathy Study; IOP, intraocular pressure.

ILUVIEN contains 190 μg of FAc and delivers 0.2 μg of FAc per day. Dugel et al1 presented the data for the 0.5 μg of FAc per day, which was studied in the FAME studies but is not the approved dose in Europe. This needs to be explained to the reader as the data that are relevant to the currently marketed product are those of the 0.2 μg of FAc per day release rate.2,4 Thus, Table 2 presented in Dugel et al has been amended to reflect the data for ILUVIEN.

A number of papers have been published on the pharmacokinetic,4 safety, and efficacy of ILUVIEN,5 and the reader can access the summary of product characteristics for ILUVIEN online.2

Disclosure

The author reports no conflicts of interest in this communication.


References

1.

Dugel PU, Bandello F, Loewenstein A. Dexamethasone intravitreal implant in the treatment of diabetic macular edema. Clin Ophthalmol. 2015;9:1321–1335.

2.

Electronics Medicine Compendium. Summary of Product Characteristics for ILUVIEN 190 micrograms intravitreal implant in applicator. Available from: https://www.medicines.org.uk/emc/medicine/27636. Accessed August 4, 2015.

3.

Alimera Sciences Press Releases. Alpharetta: Alimera Sciences, Inc. Available from: http://investor.alimerasciences.com/releases.cfm. Accessed August 4, 2015.

4.

Campochiaro PA, Nguyen QD, Hafiz G, et al; FAMOUS Study Group. Aqueous levels of fluocinolone acetonide after administration of fluocinolone acetonide inserts or fluocinolone acetonide implants. Ophthalmology. 2013;120(3):583–587.

5.

Campochiaro PA, Brown DM, Pearson A, et al; FAME Study Group. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125–2132.

Authors’ reply

Pravin U Dugel,1,2 Francesco Bandello,3 Anat Loewenstein4

1Retinal Consultants of Arizona, Phoenix, AZ, 2Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 3Department of Ophthalmology, University Vita-Salute Scientific Institute San Raffaele, Milan, Italy; 4Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Dear editor

We would like to thank Dr Hall for his interest in our recently published review article,1 and Clinical Ophthalmology for inviting us to respond to the points raised in his letter.

It should be noted that the primary aim of our article was to review the clinical efficacy and safety of dexamethasone intravitreal implant in the treatment of diabetic macular edema; for this reason only brief mention was made of other intravitreal corticosteroid delivery systems. Comparative data were limited to a short summary (Table 2) of the properties of Ozurdex® (dexamethasone intravitreal implant 0.7 mg) and ILUVIEN® (fluocinolone acetonide intravitreal implant 190 μg) – the two sustained-release intravitreal corticosteroid formulations currently approved for the treatment of diabetic macular edema. The table accurately summarizes the efficacy and safety data from the published MEAD2 and FAME3 studies – all doses investigated in these Phase III trials are presented and clearly annotated in the table. In the case of the FAME study, this includes both the low-dose (0.2 μg/day) and high-dose (0.5 μg/day) formulations of fluocinolone acetonide intravitreal implant 190 μg. The data, therefore, are relevant to the product currently marketed in Europe and the United States, ILUVIEN, which releases 0.2 μg of fluocinolone acetonide per day.

The content of the amended table presented by Dr Hall, based as it is on the European Summary of Product Characteristics for ILUVIEN, goes well beyond the scope and intent of our original table. Other than referring to the date of US Food and Drug Administration approval, our article avoids all mention of product licensing and labeling in the various regional markets. We feel that these marketing details would be out of place in a review of the scientific literature.

Disclosure

The authors report no conflicts of interest in this communication.


References

1.

Dugel PU, Bandello F, Loewenstein A. Dexamethasone intravitreal implant in the treatment of diabetic macular edema. Clin Ophthalmol. 2015;9:1321–1335.

2.

Boyer DS, Yoon YH, Belfort R Jr, et al; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121:1904–1914.

3.

Campochiaro PA, Brown DM, Pearson A, et al; FAME Study Group. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119:2125–2132.

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