Sirion Therapeutics Announces Positive Phase III Results For Difluprednate
"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
Sirion terapeutice Announces pozitive de fazã III Rezultate pentru Difluprednate - Sirion Therapeutics Announces Positive Phase III Results For Difluprednate - articole medicale engleza - startsanatate