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Sirion Therapeutics Inc. announced that a difluprednate ophthalmic emulsion 0.05% (Durezol) indicated for the treatment of inflammation and pain associated with ocular surgery is now commercially available.
Tampa, FL-Sirion Therapeutics Inc. announced that a difluprednate ophthalmic emulsion 0.05% (Durezol) indicated for the treatment of inflammation and pain associated with ocular surgery is now commercially available.
"We are excited to provide eye-care professionals with a new and powerful topical steroid," said Susan Benton, senior vice president of sales and marketing for Sirion Therapeutics. "Because [the emulsion] is the first and only steroid with an approval for both inflammation and pain, it is the first innovation in the strong steroid class in over 35 years. We believe [the corticosteroid] will give patients and physicians a more comprehensive option for postoperative care."
The company also announced the completion of two phase IIIb studies that evaluated the ophthalmic emulsion for the management of postoperative inflammation in which treatment was initiated 1 day prior to surgery. The studies were conducted in 245 patients undergoing unilateral ocular surgery, in multicenter, randomized, double-masked, placebo-controlled, parallel-group trials.
In the first study of 124 patients, the difluprednate ophthalmic emulsion 0.05% or placebo was dosed four times daily, whereas in the second study, 121 patients received the emulsion or placebo twice daily.
"The phase IIIb studies represent an approach to therapy that is most similar to the current standard of care, meaning most physicians treat inflammation prophylactically rather than waiting for it to occur," said Steven Silverstein, MD, of Silverstein Eye Centers. Dr. Silverstein was a principal investigator in the q.i.d. study and also serves as a clinical assistant professor of ophthalmology at the University of Missouri-Kansas City School of Medicine and the University of Health Sciences.
"Overall, the results from these studies show that by any definition utilized, [the ophthalmic emulsion] administered both b.i.d. and q.i.d. was more effective than placebo in treating postoperative ocular inflammation and relieving ocular pain/discomfort as early as day 3 or 4," he said.