A New Approach for Diabetic Macular Edema Treatment: review of clinical practice results with 0.19 mg fluocinolone acetonide intravitreal implant including vitrectomized eyes.

Abstract

Fluocinolone acetonide is a synthetic fluorinated glucocorticoid. It has selective and potent agonist properties by binding to the cytosolic glucocorticoid receptor with high affinity; it is devoid of mineralocorticoid activity. Two extended-release (i.e. lasting up to 3 years) drug delivery systems containing fluocinolone acetonide (FAc) have been approved by the FDA for intravitreal use: Retisert ® (Bausch&Lomb, New Jersey, USA) and Iluvien ® (Alimera Sciences, Atlanta, USA). The former contains 0.59 mg of FAc, which is approved for the treatment of chronic noninfectious posterior segment uveitis. The latter contains a dose of 0.19 mg of FAc and is approved for the treatment of diabetic macular edema and here we review the results published in the clinical literature relating to its use in the treatment of diabetic macular edema (DME). The 0.19 mg FAc implant (Iluvien®) is a new approved treatment approach for DME. It is a non-biodegradable implant that continuously releases a microdose of FAc into the vitreous cavity for up to three years. It is effective in chronic DME with the added value of decreasing the treatment burden of multiple intravitreal injections. Recently, clinical practice studies are reporting its efficacy and safety profile (intra-ocular pressure rise and cataract), as well as its use in clinical setting not included in clinical trial such as vitrectomized eyes. The FAc implant has demonstrated in clinical practice results that mirror the results of the clinical trials efficacy wise. Regarding its safety profile, cataract is a common complication, however, intra-ocular pressure rises may be lower than the ones reported in trials. The implant has shown effectiveness in vitrectomized eyes. An increasing evidence of real-world studies have supported utility of the implant in DME patients. It's extended-release format for up to 3 years benefits to the patient and carer as it means fewer injections and visits to the clinic.