Real-World Efficacy and Safety of Fluocinolone Acetonide Implant for Diabetic Macular Edema: A Systematic Review

Abstract

To assess real-world outcomes of fluocinolone acetonide (FAc) implant in treating diabetic macular edema (DME), a systematic literature review was conducted on PubMed in order to identify publications assessing the efficacy and safety of the FAc implant in DME in daily practice. Case reports and randomized controlled trials were excluded. Twenty-two observational real-world studies analyzing a total of 1880 eyes were included. Mean peak visual gain was +8.7 letters (11.3 months post-FAc injection) and was greater for lower baseline best corrected visual acuity (BCVA) and for more recent DME. Mean central retinal thickness (CRT) decreased 34.3% from baseline. 77.0% of the analyzed studies reported both BCVA improvement of at least five letters and a CRT decrease by 20% or more. Rescue therapy was needed more frequently when FAc was administered for chronic DME. FAc-induced ocular hypertension was reported in 20.1% of patients but only 0.6% needed surgery. Cataract extraction was performed in 43.2% of phakic patients. Adequate patient selection is essential for optimal FAc response and better safety profile. Currently positioned as second- or third-line treatment in the management algorithm, FAc implant decreases treatment burden and provides better letter gain when administered for more recent DME.

Prognostic biomarkers of chronic diabetic macular edema treated with a fluocinolone acetonide intravitreal implant

“…Second, those eyes had a lower percentage of DRIL and/or EZ disruption at baseline [14,15]. Third, those eyes were also less exposed to the effect of consecutive, recurrent short-acting intravitreal treatments [2,7]. The number of previous intravitreal injections was statistically different between the two groups, reflecting a possible association between these biomarkers and intravitreal injection number, supporting this hypothesis.…”

“…In its multifactorial nature, blood-retinal barrier dysfunction and inflammation may also play an important role [1,4]. Therefore, besides anti-VEGF therapy, which is considered the mainstay of DME treatment [5,6], intravitreal corticosteroids, acting mainly against the inflammatory component of DME, are becoming increasingly important, particularly in chronic or persistent DME [7][8][9]. Indeed, DME presents with a widely variable response to anti-VEGF treatment [1].…”

“…The fluocinolone acetonide (FAc) implant is a non-biodegradable corticosteroid intravitreal implant that provides controlled and sustained drug release (0.2 µg/day) during 3 years [7,12,13]. It can act against proinflammatory molecules such as VEGF-A, chemokines, and cytokines, reducing inflammation, angiogenesis, and vascular permeability [7,13]. In Europe, the FAc implant is indicated for the treatment of chronic DME, which is considered insufficiently responsive to available therapies [3,7].…”

“…It can act against proinflammatory molecules such as VEGF-A, chemokines, and cytokines, reducing inflammation, angiogenesis, and vascular permeability [7,13]. In Europe, the FAc implant is indicated for the treatment of chronic DME, which is considered insufficiently responsive to available therapies [3,7]. Despite the higher risk of cataract formation and ocular hypertension associated with intravitreal corticosteroid agents [6], there are several benefits to using FAc implants.…”

“…Despite the higher risk of cataract formation and ocular hypertension associated with intravitreal corticosteroid agents [6], there are several benefits to using FAc implants. The benefits include fewer potential systemic side effects (from repeated anti-VEGF treatments), longer treatment intervals with reduction of treatment burden, and higher patient compliance [7,8].…”