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Sirion Therapeutics Announces Positive Phase III Results for Difluprednate
Date:10/25/2007

- Data Support NDA Submission -

TAMPA, Fla., Oct. 25 /PRNewswire-FirstCall/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced positive preliminary results from its Phase III difluprednate (ST-601) program, which evaluated the steroid's potential to rapidly resolve inflammation in the eye following ocular surgery.

"We are very pleased with the data that demonstrate difluprednate's potential as a potent, well-tolerated steroid treatment for post-operative inflammation," said Dr. Roger Vogel, Sirion's Chief Medical Officer. "Based on these data, Sirion is moving forward with its plans to submit a New Drug Application to the FDA."

The Phase III program consisted of two multi-center, randomized, double- masked studies that compared the safety and efficacy of difluprednate 0.05% to placebo, dosed two (BID) or four (QID) times daily beginning 24 hours after surgery. The studies included 439 subjects who presented with Grade 2 (an inflammatory cell count greater than or equal to 10) or higher the day after surgery. Inflammation was measured by the number of cells in the anterior chamber of the eye with a Grade 0 equaling less than or equal to one cell. The primary efficacy endpoint measured the proportion of subjects whose inflammation reached Grade 0 at Day 8.

Both difluprednate dosing regimens were superior to placebo at the primary endpoint, reaching high statistical significance at Day 8 and maintaining superiority through both the treatment period (Day 15) and the tapering period (Day 29). At Day 15, 56% of subjects on the BID regimen reached Grade 0 compared to 16% in the control group (p<0.0001). Of the subjects on the QID regimen, 63% reached Grade 0 at Day 15. This was also statistically significant when compared to placebo, but not clinically different than the BID regimen. In addition, both difluprednate groups were statistically better than placebo in eliminati
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SOURCE Sirion Therapeutics, Inc.
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