Aqueous Levels of Fluocinolone Acetonide after Administration of Fluocinolone Acetonide Inserts or Fluocinolone Acetonide Implants

Campochiaro, Peter A.; Nguyen, Quan Dong; Hafiz, Gulnar; Bloom, Steven M.; Brown, David M.; Busquets, Miguel; Ciulla, Thomas A.; Feiner, Leonard; Sabates, Nelson R.; Billman, Kathleen; Kapik, Barry; Green, Ken; Kane, Frances

doi:10.1016/j.ophtha.2012.09.014

Cited by 124 publications

(123 citation statements)

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“…This is contrast to the findings in humans wherein FAc is measurable through at least month 36 following administration of the implant. 5 Interestingly, there was no quantifiable systemic exposure to FAc following intravitreal administration of the FAc implant at 0.2, 0.5, or 1.0 mg/day doses. The animals in group 3 received 2 inserts in both eyes at day 1 and week 52.…”

Section: Discussionmentioning

confidence: 95%

“…These findings are consistent with the findings of Campochiaro et al, which demonstrated that FAc levels are higher in the aqueous humor of human subjects treated with Retisert than those treated with the FAc implant through 15 months (the last time point tested). 5 This may also account for the higher rate of side effects of cataract and elevated intraocular pressure reported with Retisert compared with the FAc implant. 2,3 Limitations of this study include the sensitivity of the analytical method, which was not sufficient to evaluate the levels of FAc in the aqueous humor and in the time points after month 6 for the retina in low dose group.…”

Section: Discussionmentioning

confidence: 99%

“…5,6 Thus, the FAc intravitreal implant has achieved long-term administration of low dose of a therapeutic agent to the intended ocular tissues without significant systemic exposure. OCULAR PK OF FLUOCINOLONE ACETONIDE IN RABBITS 15…”

Section: Discussionmentioning

confidence: 99%

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Ocular Pharmacokinetics of Fluocinolone Acetonide Following Iluvien Implantation in the Vitreous Humor of Rabbits

Kane¹,

Green

2015

Journal of Ocular Pharmacology and Therapeutics

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Purpose: The purpose of this study was to evaluate the systemic and ocular pharmacokinetics (PK) of fluocinolone acetonide (FAc) following administration of Iluvien Ò intravitreal implants. Methods: The FAc intravitreal implant was administered to rabbits in 3 doses (0.2, 0.5, and 1.0 mg/day). The concentration of FAc was measured by a validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method in plasma and ocular tissues at various time points through month 24. Results: Following administration of the 0.2 mg/day implant, FAc levels peaked in most tissues at day 2 or 8, reached approximate steady state levels by month 3 and very gradually decreased over the duration of the study. The FAc level in the aqueous humor was not measurable at most time points in the rabbit. FAc was still present in most ocular tissues at 2 years. The 0.5 and 1.0 mg/day dose groups followed the same pattern through month 9. The elimination half lives in the tissues for which it was measurable were greater than 83 days. Exposure to FAc was highest in the choroid/retinal pigment epithelium for all doses, followed by lens and retina. Conclusions: The results of this study demonstrate sustained delivery of FAc from the Iluvien intravitreal implant in the ocular tissue of rabbits. Retina and lens FAc levels with the Iluvien implant were approximately 1/10 those reported with the Retisert Ò implant. FAc levels in the aqueous were not measureable with Iluvien where they were measured for 12 months with Retisert.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

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Ocular Pharmacokinetics of Fluocinolone Acetonide Following Iluvien Implantation in the Vitreous Humor of Rabbits

Kane¹,

Green

2015

Journal of Ocular Pharmacology and Therapeutics

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“…ILUVIEN in DME Ophthalmologica DOI: 10.1159/000481157 3 increase in retinal thickness secondary to recurrent or worsening DME" [2] . This is based on Campochiaro et al [6] , 2013, and not Campochiaro et al [7] , 2010, and shows that aqueous humor FAc concentrations decreased over the first 3 − 6 months and remained essentially the same through month 36 for subjects who were not retreated. Subjects who were retreated experienced a second FAc peak concentration similar to that following the initial dose.…”

Section: Characteristicsmentioning

confidence: 92%

ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

Hall¹

2017

Ophthalmologica

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“…• If you decide to add or subtract columns in your timeline (TROT), you must also adjust the mm matrix, (i in 2:12), and c (11,11,11) values in the "AUC_example.r" file.…”

Section: Calculation Of Area Under the Curvementioning

confidence: 99%

The Value of Area Under the Curve Analysis as an Outcome Measure in the Assessment of a Continuous Microdosing Fluocinolone Acetonide Implant (ILUVIEN®)

Bahadorani¹,

Singer²

2017

US Ophthalmic Review

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T he treatment of diabetic macular edema (DME) has become one of the most challenging management issues faced by ophthalmologists in daily practice. This is partly due to the multifactorial nature of DME, progression of the disease and the clinical capacity needed to administer intravitreal injections. In recent years, the treatment options for DME have expanded to include intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents and steroids, and most recently, the use of intravitreal implants. In determining clinically relevant endpoints for clinical studies of these treatments, it is important to consider the patient's journey and experience with a treatment over a specific time-period rather than isolated outcomes at a pre-specified time-point. Area under the curve (AUC) is an ideal tool for data analysis particularly when it comes to sustained release therapies such as dexamethasone (Ozurdex ® , Allergan Inc., California, US) and intravitreal fluocinolone acetonide implant (0.2µg/day FAc implant; Iluvien ® , Alimera Sciences Inc., Georgia, US). Unlike single time-point outcomes, AUC analysis provides the average letters gained per day over the entire treatment period, providing a better measure of long-term effectiveness. A recent analysis using the AUC approach highlights the significant visual acuity benefit resulting from the 0.2µg/day fluocinolone acetonide (FAc) implant during the FAME (Fluocinolone Acetonide for Macular Edema) trials. A step-by-step instruction is included in this article that allows statistical analysis of the AUC data from both functional and anatomical outcomes, using a free software tool to further facilitate the use of this technique for future investigators. KeywordsDiabetic macular edema, intravitreal implants, ILUVIEN Disclosure: Sepehr Bahadorani has nothing to declare in relation to this article.

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Aqueous Levels of Fluocinolone Acetonide after Administration of Fluocinolone Acetonide Inserts or Fluocinolone Acetonide Implants

Cited by 124 publications

References 6 publications

Ocular Pharmacokinetics of Fluocinolone Acetonide Following Iluvien Implantation in the Vitreous Humor of Rabbits

Ocular Pharmacokinetics of Fluocinolone Acetonide Following Iluvien Implantation in the Vitreous Humor of Rabbits

ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

The Value of Area Under the Curve Analysis as an Outcome Measure in the Assessment of a Continuous Microdosing Fluocinolone Acetonide Implant (ILUVIEN®)

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