Sirion has announced the preliminary results of the clinical trial comparing the safety and efficacy of Durezol (difluprednate ophthalmic emulsion; Sirion) with that of Pred Forte (prednisolone acetate ophthalmic suspension; Allergan) for the treatment of anterior segment uveitis.
The multicentre, randomized, double-masked trial enrolled subjects with endogenous anterior uveitis (n=90). The study assessed Durezol 0.05% administered four times daily and compared the results with those gained for Pred Forte 1% dosed eight times daily. Both treatment arms had the same dosing regime: 14 days of treatment, followed by 14 days of tapered half doses, and a further 14 days of follow-up.
At Day 14, the reductions in anterior chamber (AC) cell grades were 2.1 and 1.9 for the Durezol and Pred Forte groups, respectively. Symptoms associated with anterior inflammation were reduced by 76% and 71% at Day 14 for the Durezol and Pred Forte groups, respectively. Pain, assessed using a Visual Analogue Scale, was reduced at Day 7 by 71% and 64% for the Durezol and Pred Forte groups, respectively. In both the Durezol and the Pred Forte groups, two patients experienced a statistically significant increase in intraocular pressure (IOP). 12.5% of Pred Forte patients withdrew from the study due to lack of efficacy and 0% of Durezol patients withdrew for this reason.
Durezol is currently indicated for postoperative inflammation and pain. Sirion now plans to combine this trial data with other results from a Japanese study to support the filing of a supplemental New Drug Application (sNDA) for anterior uveitis.