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M. Mochizuki, S. Ohno, M. Usui, K. Masuda, T. Sekiya, T. Ogawa, DFBA Study Group; A Phase III, Open-Label, Clinical Study of Difluprednate Ophthalmic Emulsion (DFBA), 0.05% in the Treatment of Severe Refractory Anterior Uveitis. Invest. Ophthalmol. Vis. Sci. 2007;48(13):3905.
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To assess the safety and efficacy of difluprednate ophthalmic emulsion (DFBA), 0.05% in severe endogenous anterior uveitis that did not respond to previous therapies.
19 patients aged 23-66 years received 1 drop of DFBA QID for 14 days. All patients had severe endogenous anterior uveitis (anterior chamber cell score 4+) even on betamethasone 0.1% instillation (QID). The primary measure of efficacy was the change from baseline (day 0) to day 14 in anterior chamber cell score. Secondary measures of efficacy included the change from baseline to days 3 and 7 in anterior chamber cell score, change from baseline to days 3, 7 and 14 in total sign, total symptom and anterior chamber flare scores. The numbers of patients with an anterior chamber cell score of 0 or 1+ were also evaluated. Safety measurements were made during the study period, except laboratory tests performed at baseline and Day 14.
Of the 19 patients, all patients were included in the safety analysis. Eighteen patients completed the study and were included in the efficacy evaluation. Treatment with DFBA showed a statistically significant improvement from baseline (4.0 ± 0.0(mean ± SD)) to day 14 (1.3 ± 0.8) in mean anterior chamber cell score (P<0.0001). A statistically significant improvement from baseline to day 3 (P<0.0001) and to day 7 (P<0.0001) was also noted. Significant improvements from baseline in anterior chamber flare, total sign and total symptom scores were noted at days 3, 7 and 14 (P≤0.0002 at all measures). In 13 patients (72.2%), an anterior chamber cell score improved to 1+ or lower at day 14. An anterior chamber cell score in 2 patients disappeared with DFBA treatment. Of the 19 patients, 5 patients (26.3%) experienced a total of 6 adverse drug reactions (ADRs). ADRs included punctuate keratitis, and increased IOP. All ADRs were transient and mild to moderate in severity; no clinically significant adverse events occurred in the study.
DFBA instillation given QID for 14 days was effective in reducing the anterior chamber cell, flare, and total sign and symptom scores in patients with severe endogenous anterior uveitis. DFBA was well tolerated; all ADRs were mild to moderate in severity and transient.
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