Sustained-release fluocinolone acetonide intravitreal insert for macular edema: Clinical pharmacology and safety evaluation

Mohammad Ali Sadiq, Aniruddha Agarwal, Mohamed K. Soliman, Mostafa Hanout, Salman Sarwar, Diana V. Do, Quan Dong Nguyen

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Introduction: Inflammation plays a key role in the pathological processes leading to macular edema. Sustained release, low-dose intraocular corticosteroid delivery devices provide long-term anti-inflammatory therapy. Recently, a novel fluocinolone acetonide intravitreal insert (FAi, Iluvien), has been introduced with promising long-term results in the treatment of macular edema.Areas covered: An extensive review of the literature in the English language was performed to provide comprehensive information on the pharmacological properties of FAi and its safety and efficacy data from various multi-center randomized clinical trials.Expert opinion: The FAc, Retisert is a sustained-release device that is surgically implanted in the vitreous and has been approved by the US FDA for the treatment of non-infectious intermediate, posterior or panuveitis. FAi was developed after FAc and is an intravitreal corticosteroid delivery system that allows controlled release of therapeutic levels of fluocinolone acetonide (FA). Initial efficacy and safety data suggest that this delivery system maintains clinical effectiveness for up to 3 years after a single delivery of the device. This second-generation fluocinolone delivery device has shown superior safety results in clinical trials compared to the previous version of the higher dose FAc (0.59 mg). Sustained delivery preparations may help to reduce the treatment burden and its associated risks by decreasing the frequency of intravitreal injections. However, much needs to be learnt from additional clinical trials, post-marketing surveillance and results of extension studies. Concerns of intravitreal corticosteroids, such as cataract and increase in intraocular pressure, remain major challenges for this therapeutic strategy.

Original languageEnglish (US)
Pages (from-to)1147-1156
Number of pages10
JournalExpert Opinion on Drug Safety
Volume14
Issue number7
DOIs
StatePublished - Jan 1 2015

Fingerprint

Fluocinolone Acetonide
Macular Edema
Clinical Pharmacology
Safety
Equipment and Supplies
Adrenal Cortex Hormones
Therapeutics
Panuveitis
Clinical Trials
Intravitreal Injections
Expert Testimony
Pathologic Processes
Marketing
Intraocular Pressure
Cataract
Anti-Inflammatory Agents
Language
Randomized Controlled Trials
Pharmacology
Inflammation

Keywords

  • Fluocinolone acetonide
  • Implant
  • Intraocular injection
  • Intravitreal steroid
  • Macular edema
  • Steroid
  • Sustained release

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Sustained-release fluocinolone acetonide intravitreal insert for macular edema : Clinical pharmacology and safety evaluation. / Sadiq, Mohammad Ali; Agarwal, Aniruddha; Soliman, Mohamed K.; Hanout, Mostafa; Sarwar, Salman; Do, Diana V.; Nguyen, Quan Dong.

In: Expert Opinion on Drug Safety, Vol. 14, No. 7, 01.01.2015, p. 1147-1156.

Research output: Contribution to journalArticle

Sadiq, Mohammad Ali ; Agarwal, Aniruddha ; Soliman, Mohamed K. ; Hanout, Mostafa ; Sarwar, Salman ; Do, Diana V. ; Nguyen, Quan Dong. / Sustained-release fluocinolone acetonide intravitreal insert for macular edema : Clinical pharmacology and safety evaluation. In: Expert Opinion on Drug Safety. 2015 ; Vol. 14, No. 7. pp. 1147-1156.
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