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Drug Safety Evaluation

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

Mohammad Ali SadiqUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), Omaha, NE 68198-5540, USA

, MD (Post Doctoral Research Fellow) ,

Aniruddha AgarwalUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), Omaha, NE 68198-5540, USA

, MD (Post Doctoral Research Fellow) ,

Mohamed K SolimanUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), Omaha, NE 68198-5540, USA

, MD (Post Doctoral Research Fellow) ,

Mostafa HanoutUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), Omaha, NE 68198-5540, USA

, MD (Post Doctoral Research Fellow) ,

Salman SarwarUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), Omaha, NE 68198-5540, USA

, MD (Post Doctoral Research Fellow) ,

Diana V DoUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), Omaha, NE 68198-5540, USA

, MD (Associate Professor) &

Quan Dong NguyenUniversity of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Ocular Imaging Research and Reading Center (OIRRC), 985540 Nebraska Medical Center, Omaha, NE 68198-5540, USA+1 402 559 4276; +1 402 559-5514; [email protected]

, MD MSc (Professor and Chairman) show all

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.

Keywords:

Declaration of interest

QD Nguyen and DV Do serve on the scientific advisory boards for Genentech Inc. and Regeneron Inc. QD Nguyen also serves on the scientific advisory board of Bausch & Lomb Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Notes

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