DurezolTM Compared to Pred Forte® in the Treatment of Endogenous Anterior Uveitis

Abstract

Purpose: : Evaluate the efficacy of Durezol<font face="Symbol">Alt+Ctrl+T</font> (difluprednate ophthalmic emulsion, 0.05%) dosed 4x/day (QID) for 14 days, versus Pred Forte&reg; (prednisolone acetate suspension), 1%, dosed 8x/day for 14 days in treating endogenous anterior uveitis.

Methods: : A randomized, multicenter, double-masked noninferiority trial was conducted in 90 subjects, comparing Durezol QID to Pred Forte dosed 8x/day. Both groups were treated with the test agent for 14 days, followed by 2 weeks of tapering at half the dose, and 2 weeks of follow-up. Subjects aged 2 or older with endogenous anterior uveitis in at least 1 eye and more than 10 cells and a flare score of ≥ 2 in the anterior chamber (AC) of that same eye were eligible for participation. Subjects were randomized 1:1 to receive either Durezol QID or Pred Forte 8x/day. The primary endpoint was the difference from baseline in AC cell grades between the treatment groups.

Results: : At Day 14 Durezol achieved a mean cell grade reduction of 2.1 vs 1.9 for Pred Forte, confirming the noninferiority of Durezol QID to Pred Forte dosed 8x/day. A greater percentage of Durezol-treated patients had an AC cell grade of 0 (≤ 1 cell) than the Pred Forte on Day 14 (69% vs 62%, respectively). By Day 7, Durezol provided a reduction in the mean pain score of 71% versus 64% in the Pred Forte-treated group. The Durezol group showed a greater reduction in total sign score (6.5) when compared to Pred Forte (6.1) at Day 14. This numerical advantage continued throughout the study period. In the Pred Forte-treated group, 12.5% of patients were withdrawn due to lack of efficacy or worsening of symptoms; no Durezol patients were withdrawn for these reasons (P = 0.01). Two patients in each treatment arm (Durezol group: 4.2%; Pred Forte group: 5.1%) experienced a criterion increase in intraocular pressure (defined as ≥ 21 mmHg and a change from baseline ≥ 10 mmHg at the same visit).

Clinical Trial: : www.clinicaltrials.gov NCT00501579

Keywords: uveitis-clinical/animal model • corticosteroids • inflammation