Iluvien: a new sustained delivery technology for posterior eye disease.

Iluvien (fluocinolone acetonide intravitreal insert, Alimera Sciences, Inc.), a novel injectable intravitreal insert, is being studied to deliver a very low dose of a corticosteroid to the retina for up to 3 years as a treatment for diabetic macular edema. Using a proprietary 25-gauge injector system, an ophthalmologist injects the Iluvien insert, which uses the Medidur (Alimera Sciences, Inc.) technology, into the vitreous through a minimally invasive procedure in an out-patient setting. The placement of the device in the inferior vitreous has the potential to maximize drug at the retina while reducing exposure of the anterior chamber. Phase III studies are underway to test the safety and efficacy of Iluvien. This article offers a specific review of the Iluvien technology rather than an overview of the various intravitreal methods of treating posterior eye disease.

Ocular pharmacokinetics of fluocinolone acetonide following Iluvien implantation in the vitreous humor of rabbits.

PURPOSE: The purpose of this study was to evaluate the systemic and ocular pharmacokinetics (PK) of fluocinolone acetonide (FAc) following administration of Iluvien(®) intravitreal implants. METHODS: The FAc intravitreal implant was administered to rabbits in 3 doses (0.2, 0.5, and 1.0 µg/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 µg/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 µg/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(®) implant. FAc levels in the aqueous were not measureable with Iluvien where they were measured for 12 months with Retisert.