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news.Sirion Therapeutics, a privately held ophthalmic-focused biopharmaceutical company, has announced positive preliminary results from a pivotal anterior uveitis trial that compared Durezol 0.05% dosed four times daily to Pred Forte 1%, dosed eight times daily.
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Approximately 90 patients with endogenous anterior uveitis were studied in a multicenter, randomized, double-masked trial that compared the efficacy and safety of Durezol four times daily (QID) with Pred Forte eight times a day. Treatment for both study groups was administered for 14 days, with two weeks of tapering at half the dose and two weeks of follow-up (for a total 42 days) after initiation of therapy.
The primary endpoint was the difference from baseline in anterior chamber (AC) cell grades between the Durezol and Pred Forte groups. At day 14, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, confirming the noninferiority of Durezol dosed QID to Pred Forte dosed eight times a day.
In addition to reducing mean cell grade, a greater percentage of patients receiving Durezol had an AC cell grade of zero (less than or equal to one cell) than did the Pred Forte group at day 14 (69% versus 62%, respectively). This trend continued through day 42.
In this study, pain was assessed using a visual analog scale. Durezol demonstrated a numerical advantage in pain reduction from baseline over Pred Forte at every time point in the study. As early as day three, the Durezol group had a reduction in mean pain score of 58% versus 51% in the Pred Forte group. At day seven, these were 71% and 64%, respectively. Durezol was also very effective in reducing the symptoms of anterior ocular inflammation (pain/ocular discomfort, photophobia, blurred vision, and lacrimation).
Barry Butler, CEO and president of Sirion Therapeutics, said: “The results from this study will be combined with data from previous trials conducted in Japan to support a supplemental new drug application for anterior uveitis.
“Although this study was not designed to detect the statistical superiority of one drug over the other, the consistent numerical advantage of Durezol across all endpoints is impressive. This is especially so, when you consider that Pred Forte has 20 times the concentration of Durezol and was dosed twice as often. This clearly demonstrates the potency of Durezol.”