A New Approach for Diabetic Macular Edema Treatment: Review of Clinical Practice Results with 0.19 mg Fluocinolone Acetonide Intravitreal Implant Including Vitrectomized Eyes

  • Raquel Estebainha
  • Raquel Goldhardt
  • Manuel FalcãoEmail author
Retina (R Goldhardt, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Retina
  2. Topical Collection on Retina


Purpose of Review

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, NJ, USA) and Iluvien® (Alimera Sciences, Atlanta, USA). The former contains 0.59 mg of FAc, which is approved for the treatment of chronic non-infectious 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).

Recent Findings

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 3 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 (intraocular 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, intraocular 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 has supported utility of the implant in DME patients. Its extended-release format for up to 3 years benefits the patient and carer as it means fewer injections and visits to the clinic.


Diabetic macular edema Intravitreal corticosteroids Long-acting corticosteroids, diabetic retinopathy 


Funding Information

This manuscript received financial support the National Institutes of Health Center Core Grant (P30 EY014801), research to prevent blindness unrestricted grant.

Compliance with Ethical Standards

Conflict of Interest

Raquel Estebainha declares no potential conflicts of interest.

Raquel Goldhardt is section editor of the Retina section of Current Ophthalmology Reports.

Manuel Falcão has received travel grants from Alimera, Allergan, Bayer, and Novartis and received lecture honoraria from Alimera and Bayer.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2020

Authors and Affiliations

  • Raquel Estebainha
    • 1
  • Raquel Goldhardt
    • 2
    • 3
  • Manuel Falcão
    • 4
    • 5
    Email author
  1. 1.Faculty of Medicine of the University of PortoPortoPortugal
  2. 2.Miami Veterans Administration Medical CenterMiamiUSA
  3. 3.Department of Ophthalmology, Bascom Palmer Eye InstituteUniversity of MiamiMiamiUSA
  4. 4.Department of Surgery and Physiology, Faculty of MedicineUniversity of PortoPortoPortugal
  5. 5.Department of OphthalmologyCentro Hospitalar Universitario S. JoãoPortoPortugal

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