<p>Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE</p>

Abstract

Purpose: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant is approved in the United Arab Emirates (UAE) for treating diabetic macular edema (DME) in patients previously treated with a course of corticosteroids and that did not have a clinically significant rise in intraocular pressure (IOP). This ongoing study is assessing its effectiveness and safety in pseudophakic patients with DME in clinical practice from a single center in the UAE. Methods: A retrospective, ongoing 6-month audit study (NCT03590587), in which 22 eyes from 22 patients were treated with a single FAc intravitreal implant after treatment with a prior course of corticosteroids. Outcomes assessed included mean changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and IOP. Six-month follow-up data are presented. Results: After FAc implantation, mean BCVA improved rapidly, increasing by 25.4 ± 3.0 letters (mean±SEM) from baseline to Month 6 (p<0.0001). At 6 months, BCVA had improved by 15 letters or more in 91% of eyes (n=20/22). Mean CMT decreased by 267.0 ± 20.1 µm from baseline to Month 6 (p<0.0001). Over 85% of eyes (n=19/22) had a CMT less than 300 µm at 6 months. Mean IOP increased by 2.9 ± 0.7 mmHg from baseline to Month 6 (p<0.001). All eyes except 2 had an IOP of 21 mmHg or lower. At Month 6, five eyes (23%) needed IOP-lowering therapy. Conclusion: Injection of the FAc intravitreal implant rapidly and significantly improved BCVA and CMT within 6 months. These rapid and significant improvements exceed those reported in other real-world studies. Safety signals were consistent with corticosteroid class effects. The FAc implant may be a useful treatment option for patients in the UAE, particularly those with sight threatening DME requiring rapid functional improvements.

Effectiveness and tolerability of the fluocinolone acetonide implant in patients with diabetic macular edema in the UAE: 24 and 36-month outcomes

“…In this retrospective, real-world study, a single injection of the FAc implant demonstrated rapid improvements in BCVA and CMT that were maintained at Month 24 and, in those studied, sustained up to Month 36. These findings support those previously reported 25, 26 , and describe the longevity of the effectiveness of the FAc implant in a real-world setting. The long-term safety of the FAc implant, as assessed by IOP, was consistent with previous reports and with corticosteroid class effects.…”

“…24 The 6-and 12-month outcomes of this study, which showed rapid structural and functional improvements that were maintained to 12 months, have previously been described. 25,26 The objective of this study was to assess the effectiveness and safety of the FAc implant at 24-and 36-months in patients with DME and a pseudophakic lens treated in the UAE.…”

<p>Effectiveness of 190 μg Fluocinolone Acetonide and 700 μg Dexamethasone Intravitreal Implants in Diabetic Macular Edema Using the Area-Under-the-Curve Method: The CONSTANT Analysis</p>

“…However, that being said, there are a growing number of studies that report outcomes with the DEX implant [6][7][8][9][10][11] and some that even report the use of a FAc implant after prior therapy with DEX implants, in both vitrectomised [22][23][24] and non-vitrectomised eyes. 25,26 Others have also compared outcomes achieved with the FAc implant after prior therapy with anti-VEGF. 25 Few studies report a standardised approach to changing therapy, as studies seem to report outcomes in patients that have been heavily pre-treated before being treated with the FAc implant.…”

The 0.19 mg Fluocinolone Acetonide Intravitreal Implant – A Review on its Use in Diabetic Macular Oedema from the Association for Research in Vision and Ophthalmology Annual Meeting 2018

“…These were a series of small case studies from around the world, in which the findings were remarkably consistent, with most showing improvements in VA and reductions in central retinal thickness (CRT). [30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] Augustin presented the 3-year results from a German retrospective study (Retro-IDEAL) involving 81 eyes (63 patients) and showed improvements in mean VA at month 6 (+ 4.6 letters) were maintained to year 2 (+ 4.3 letters) before declining slightly at year 3 (+ 2.6 letters). 34…”

“…The consistent reporting of improvements in VA and retinal anatomy by numerous centres at the ARVO 2018 Annual Meeting 32,36,38,43,45,46 is testimony to the value of this therapy in the treatment of persistent or recurrent DMO. 30,31,34,35,37,42 In addition, emerging evidence shows that patients with DMO, who were insufficiently responsive to intravitreal anti-VEGF drugs, dexamethasone implants and/or focal laser therapy, experienced additional improvements in function after administration of the FAc implant, 45 which raises the important question whether current use of the FAc implant in clinical practice (that is, once DMO has been defined as persisting or recurring after treatment) is optimal.…”