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Diabetic Macular Oedema Real-world Experience of Fluocinolone Acetonide (0.2 µg/day) Intravitreal Implant in the Treatment of Diabetic Macular Oedema Fahd Quhill Consultant, Department of Ophthalmology, Royal Hallamshire Hospital, Glossop Road, Sheffield, South Yorkshire, UK Abstract Fluocinolone acetonide intravitreal implant (ILUVIEN ® , FAc intravitreal implant) is approved for clinical use in Europe and US for the treatment of diabetic macular oedema (DMO). In Europe, the implant is indicated for chronic DMO patients who are insufficiently responsive to available therapies. The use of FAc intravitreal implants has been shown to be effective in pivotal clinical trial studies. Case reports and case series of FAc intravitreal implants in chronic DMO are now emerging and combined analysis of these reveals interesting findings that complement the findings in the clinical studies. Visual improvement and central retinal thickness reductions are similar to those of the clinical trials, which is surprising given that treatments often perform less well in the real-world. In addition, the incidence of intraocular pressure (IOP) elevations is lower than reported in the clinical studies. However, further follow-up is ongoing and this needs to be confirmed in a larger population of subjects. This article reviews some of these important real-world data and their likely impact on future chronic DMO treatment practice as well as the impact in terms of the functional benefit to patients with impaired vision. Keywords Diabetic macular oedema (DMO), corticosteroids, fluocinolone acetonide intravitreal implant Disclosure: Fahd Quhill has attended advisory boards and speaker engagements and has been remunerated for these by Alimera Sciences.. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 26 May 2015 Accepted: 22 June 2015 Citation: European Ophthalmic Reveiw, 2015;9(1):42–6 Correspondence: Fahd Quhill, Consultant, Department of Ophthalmology, Royal Hallamshire Hospital, Glossop Road, Sheffield, South Yorkshire, S10 2JF, UK. E: fahd.quhill@sth.nhs.uk Support: The publication of this article was supported by Alimera Sciences. Medical writing assistance was provided by James Gilbart at Touch Medical Media, supported by Alimera Sciences. Diabetic macular oedema (DMO), a pathological condition characterised by the breakdown of the blood–retina barrier and a consequent increase in vascular permeability, is one of the most challenging conditions faced by ophthalmologists today, and its prevalence is rising. The global prevalence of diabetic retinopathy among individuals with diabetes is around 35 %, with DMO present in 6.8 %. 1 Despite the success of agents targeted against vascular endothelial growth factor (VEGF) including ranibizumab, 2,3 bevacizumab 3 and aflibercept, 4 significant unmet needs remain in the treatment of chronic DMO; around a third or more of patients are considered insufficiently responsive to anti-VEGF therapy. 5 Recent research has elucidated the multi-factorial pathogenesis of DMO and focused on patients with advanced disease, who exhibit numerous inflammatory changes in the eye. 6–9 At this stage, VEGF is no longer primarily responsible for the biochemical and physiological changes in the eyes and anti-VEGF agents are consequently inappropriate as DMO is a multi-factorial disease. 10,11 These findings in DMO pathogenesis have led to a resurgence of interest in corticosteroids, which suppress multiple pathways of inflammation and reduce damage to the blood–retina barrier. 12 Intravitreal steroids, particularly in sustained-release implants, offer an alternative therapeutic strategy, providing localised delivery of the corticosteroid to maximise its anti-inflammatory, angiostatic and anti-permeability effects, as well as minimising the risks of systemic toxicity. 13 Treatment options include: 42 a dexamethasone implant (Ozurdex ® ), the fluocinolone acetonide (FAc) intravitreal implant and intravitreal triamcinolone acetonide (TA) injection (the latter is not approved for treating DMO in Europe). ILUVIEN ® (fluocinolone acetonide) delivers 0.2 µg/day of FAc and is the only therapy approved for the treatment of chronic DMO. 14 It received marketing authorisation in a number of European countries as well being approved by the US Food and Drug Administration for the treatment of DMO. 15,16 This article aims to assess some recently published case series reports of the early use of FAc intravitreal implants in a real-world setting at treatment centres in Germany and the UK, as well as assessing their impact on future chronic DMO treatment practice. Clinical Background of the Fluocinolone Acetonide Intravitreal Implant The FAc intravitreal implant is a non-bioerodible micro-implantable cylindrical tube (3.5 mm × 0.37 mm) made from polyimide and loaded with 190 µg of FAc 17 that is inserted into the vitreous cavity using a 25-gauge injector, which creates a self-sealing wound. The implant releases 0.2 µg/day of FAc for up to 36 months. 17 The pivotal Fluocinolone Acetonide for Macular Edema (FAME) clinical trials were two large prospective, randomised, controlled studies that followed 953 eyes randomised to receive 0.2 μg/day of FAc (low dose; the licensed dose) or 0.5 μg/day of FAc (high dose) implants or sham. After 3 years, substantial improvements were seen in mean visual acuity in 768 patients treated Tou c h ME d ica l ME d ia