Iontophoretic Dexamethasone Phosphate Compared to Topical Prednisolone Acetate 1% for Noninfectious Anterior Segment Uveitis. Am J Ophthalmol 2019;Abstract.
PURPOSE: To evaluate the safety and efficacy of dexamethasone phosphate ophthalmic solution (EGP-437) delivered by transscleral iontophoresis using the EyeGate® II Drug Delivery System, compared to topical prednisolone acetate 1% (PA 1%), in subjects with noninfectious anterior uveitis. DESIGN: Prospective, randomized, double-masked, parallel-group, non-inferiority clinical trial METHODS: A total of 193 subjects with active noninfectious anterior uveitis (anterior chamber [AC] cell count ≥11 cells) were randomized to EGP-437 delivered via iontophoresis (Days 0 and 7) or self-administered PA 1% daily (tapered schedule, Days 0-28). Masking was maintained with placebo iontophoresis/eyedrops. The primary efficacy endpoint was the proportion of subjects with an AC cell count of zero on Day 14; noninferiority of EGP-437 was defined if the lower limit of the confidence interval for the difference (EGP-437 minus PA 1%) was less than -10%. RESULTS: At Day 14, 32/96 (33.3%) EGP-437 subjects and 32/97 (33.0%) PA 1% subjects had an AC cell count of zero (difference [95% confidence interval], 0.34 [-12.94, 13.63]; P=0.064). Efficacy trended better with EGP-437 among patients with more severe baseline uveitis (AC cell count >25). Safety and tolerability were good with both treatments. EGP-437 subjects experienced fewer IOP elevations ≥6 mm Hg versus PA 1% subjects (13 vs 24 incidents through Day 28). CONCLUSIONS: Despite clinically similar response rates, statistical noninferiority of EGP-437 versus a tapered regimen of PA 1% was not achieved. Numerical trends suggesting fewer IOP elevations with EGP-437, similar efficacy overall, and possibly better efficacy in more severe disease warrant further study.