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Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
Date:10/14/2008

as every 15-30 minutes in more severe cases. In addition, Durezol does not contain benzalkonium chloride (BAK), a common ocular preservative known to cause corneal toxicity with long-term use. This is especially important for patients with uveitis, which is a chronic disease. A strong steroid like Durezol will be a very valuable tool for ophthalmologists everywhere, allow patients to have an easier dosing regimen, and will most likely become the new standard of care for treating uveitis."

In addition to reducing mean cell grade, a greater percentage of patients receiving Durezol had an AC cell grade of 0 (less than or equal to 1 cell) than did the Pred Forte group at Day 14 (69% vs 62%, respectively). This trend continued through Day 42.

Ocular discomfort and pain is a debilitating symptom of uveitis. 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 3, the Durezol group had a reduction in mean pain score of 58% vs 51% in the Pred Forte group. At Day 7, 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). The Durezol group achieved a mean reduction in total symptom score of 76% vs 71% for Pred Forte at Day 14. This numerical difference was maintained through Day 42 with the Durezol group reducing the total symptom score by 86% vs 76% for the Pred Forte group.

The total sign score was also reduced to a greater degree in the Durezol group when compared to the Pred Forte group: 6.5 vs 6.1 at Day 14, respectively. Total sign score included the sums of posterior synechiae, hypopyon, limbal injection, peripheral anterior synechiae, AC flare, AC cell and keratic precipitate grades. The numerical advantage of Durezol over Pred Forte in total sign score
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SOURCE Sirion Therapeutics, Inc.
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