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P. A. Campochiaro, G. Hafiz, S. M. Shah, Q. D. Nguyen, The FAMOUS Study Group; Pharmacodynamics of IluvienTM, a Fluocinolone Acetonide Sustained Delivery Vitreous Insert. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1676.
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Two doses of IluvienTM have been developed to provide long term sustained, low dose delivery of fluocinolone acetonide (FA). At 3 and 6 months after intraocular insertion of low or high dose Iluvien in patients with diabetic macular edema (DME), we measured intraocular and systemic levels of FA, change from baseline in best corrected visual acuity (BCVA) and OCT center subfield thickness (CST) and evaluated safety outcomes.
Thirty seven subjects with DME and CST ≥250µm were randomized to low (20 subjects) or high dose (17 subjects) Iluvien. At 3 and 6 months after insertion, levels of FA were measured in plasma and aqueous humor by LC-MS/MS and compared to mean change from baseline in BCVA and CST.
The plasma levels of FA were below the limit of quantification (0.1ng/mL) in all subjects for both time points. The change in aqueous FA levels, BCVA and CST from baseline for the 3 and 6 month time points are described in the table below. Cataract and epiretinal membrane contributed to a decrease in BCVA in 2 patients of the low dose group at 6 months. IOP elevation > 30mmHg occurred in no patients in the low dose group and 12% of patients in the high dose group.
This is the first study to measure intraocular levels of drug achieved with a sustained delivery insert and correlate them with clinical outcomes. The improvement in BCVA associated with reduction in CST in a substantial number of patients and low incidence of elevated IOP are encouraging.
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