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      Intravitreal Fluocinolone Acetonide Implant (ILUVIEN ®) for the Treatment of Retinal Conditions. A Review of Clinical Studies


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          Fluocinolone acetonide (FAc) intravitreal implant (Iluvien ®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non–infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.

          Most cited references65

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          Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature.

          Intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents is increasingly used for the treatment of a wide variety of retinal diseases, including age-related macular degeneration, diabetic retinopathy and retinal vascular occlusions, and retinopathy of prematurity. Despite encouraging results in halting the disease and improving the vision, intravitreal injection of anti-VEGF agents may be associated with systemic adverse events and devastating ocular complications. In this review, we provide an overview of safety data for intravitreal injection of common anti-VEGF agents.
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            Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema.

            To assess the efficacy and safety of intravitreal inserts releasing 0.2 μg/day (low dose) or 0.5 μg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials. Subjects with persistent DME despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393). Subjects received study drug or sham injection at baseline and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year. The primary outcome was the percentage of patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Trial (ETDRS) letter score of 15 or more at month 24. Secondary outcomes included other parameters of visual function and foveal thickness (FTH). The percentage of patients with improvement from baseline ETDRS letter score of 15 or more at month 24 was 28.7 and 28.6 in the low- and high-dose insert groups, respectively, compared with 16.2 in the sham group (P = 0.002 for each). Benefit occurred for both doses compared with sham at 3 weeks and all subsequent time points. The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group (P = 0.02 and P = 0.016). At all time points compared with sham, there was significantly more improvement in FTH. Subjects requiring cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma requiring incisional surgery occurred in 3.7%, 7.6%, and 0.5% of the low-dose, high-dose, and sham groups, respectively. Both low- and high-dose FA inserts significantly improved BCVA in patients with DME over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in patients with DME for at least 2 years. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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              Diabetic macular oedema.

              Diabetic macular oedema, characterised by exudative fluid accumulation in the macula, is the most common form of sight-threatening retinopathy in people with diabetes. It affects one in 15 people with diabetes resulting in more than 20 million cases worldwide. Few epidemiological studies have been done to specifically investigate risk factors for diabetic macular oedema, although poor glycaemic and blood pressure control are associated with the presence and development of the disorder. The pathophysiological processes begin with chronic hyperglycaemia, and interplay between vascular endothelial growth factor (VEGF) and inflammatory mediators. Non-invasive imaging using optical coherence tomography has allowed clinicians to detect mild levels of diabetic macular oedema in order to monitor progress and guide treatment. Although focal or grid laser photocoagulation was the traditional mode of treatment, intraocular pharmacotherapy with anti-VEGF agents is now the standard of care. However, these therapies are expensive and resource intensive. Emerging therapeutic strategies include improving efficacy and duration of VEGF suppression, targeting alternative pathways such as inflammation, the kallikrein-kinin system, the angiopoietin-Tie2 system, and neurodegeneration, and using subthreshold and targeted laser therapy. Ongoing research should lead to improvements in screening, diagnosis, and management of diabetic macular oedema.

                Author and article information

                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                30 March 2023
                : 17
                : 961-975
                [1 ]Department of Ophthalmology, Queen’s Medical Centre, Nottingham University Hospitals NHS Trust & School of Medicine, University of Nottingham , Nottingham, UK
                [2 ]Department of Acute Medicine, Luton and Dunstable University Hospitals NHS Trust , Luton, UK
                [3 ]Department of Ophthalmology, Basel University Hospital & University of Basel School of Medicine , Basel, Switzerland
                [4 ]Ophthalmology Unit, “Fondazione Policlinico Universitario A. Gemelli IRCCS” , Rome, Italy
                [5 ]Department of Ophthalmology, William Harvey Hospital, East Kent Hospitals University NHS Foundation Trust , Kent, UK
                Author notes
                Correspondence: Georgios D Panos, Department of Ophthalmology, Queen’s Medical Centre , Derby Road, Lenton, Nottingham, NG7 2UH, UK, Tel +44 115 924 9924, Email gdpanos@gmail.com
                Lorenzo Motta, Department of Ophthalmology, William Harvey Hospital , Kennington Road, Willesborough, Ashford, Kent, TN24 0LZ, UK, Tel +44 1233 633331, Email lorenzo.motta@nhs.net

                These authors contributed equally to this work

                Author information
                © 2023 Mushtaq et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                : 13 January 2023
                : 22 March 2023
                Page count
                Figures: 0, Tables: 3, References: 71, Pages: 15

                Pharmacology & Pharmaceutical medicine
                iluvien,steroid implant,diabetic macular oedema,intravitreal implant,posterior uveitis,retinal vein occlusion


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