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news.Ophthalmic-focused biopharmaceutical firm Sirion Therapeutics has reported positive preliminary results from its Phase III difluprednate program evaluating the steroid's potential to rapidly resolve inflammation in the eye following ocular surgery.
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The Phase III program consisted of two 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 II (an inflammatory cell count greater than or equal to 10) or higher the day after surgery.
Both difluprednate dosing regimens were superior to placebo at the primary endpoint, reaching high statistical significance at day eight 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. 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 eliminating pain as measured using the visual analogue scale.
Dr Roger Vogel, Sirion’s chief medical officer, said: “Based on these data, Sirion is moving forward with its plans to submit a new drug application to the FDA.”