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M. A. Patane, A. Cohen, J. Sugarman, S. From; Randomized, Double-Masked Study of Four Iontophoresis Dose Levels of EGP-437 in Non-Infectious Anterior Segment Uveitis Subjects. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5263.
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Corticosteroids are commonly used to treat acute and chronic anterior uveitis. Early, aggressive intervention delivers the best therapeutic responses. This Phase 1/2 study was designed to: 1) Establish safe, effective iontophoretic dose(s) of EGP-437 (dexamethasone phosphate formulated for iontophoresis) in non-infectious anterior uveitis subjects, and 2) Evaluate the systemic pharmacokinetic (PK) profile after a single iontophoretic administration of EGP-437 at 4 different doses.
Subjects were randomized into 1 of 4 iontophoresis dose groups (1.6, 4.8, 10, and 14 mA-min), treated once with EGP-437 via the EyeGate® II System, and followed for 4 weeks (5 visits). Ophthalmic evaluations included: Anterior chamber cell (ACC) count, slit lamp, BCVA, IOP, and fundus. Safety labs were drawn at screening and Days 14 and 28. Blood for PK analysis was drawn (4 time points).
42 subjects were enrolled; 40 completed the study. For the Full Analysis Set (FAS) and Per Protocol (PP) set, the highest proportion of subjects with an ACC score and count of zero at Days 7, 14, and 28 was found in the 1.6 mA-min treatment group. Of the non-rescued PP subjects, the proportions of ACC scores of zero were: 7 of 8 (1.6 mA-min), 5 of 8 (4.8 mA-min), 5 of 10 (10 mA-min), and 4 of 8 (14 mA-min). Kaplan-Meier analysis of time to ACC score of zero produced median values of: 11.5 days (1.6 mA-min), 15.0 days (4.8 mA-min), 22.0 days (10 mA-min), and 31.0 days (14 mA-min), with 2, 4, 5, and 5 censored (rescued or ACC score >0 at Day 28) subjects in the respective groups. Mean Cmax plasma dexamethasone and dexamethasone phosphate levels were <10 ng/mL.36/40 subjects experienced 134 adverse events (AEs), mostly mild. 34/40 subjects reported 104 ocular AEs; the most common were conjunctival hyperaemia, punctate keratitis, and conjunctival edema. No SAEs occurred.
Results showed that a single ocular iontophoretic treatment of EGP-437 via the EyeGate® II System can safely and effectively treat anterior uveitis. The most effective dose appeared to be 1.6 mA-min. Low plasma drug levels were detected. No SAEs occurred; most AEs were mild.
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