Sirion Therapeutics Highlights Pivotal Trial Results of Durezol(TM) at the American Society of Cataract and Refractive Surgery Annual Symposium
TAMPA, Fla., April 8, 2008 -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today the presentation of data from two Phase 3 clinical trials of Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid in the treatment of postoperative ocular inflammation. The results were given in a presentation by Michael Korenfeld, MD during the American Society of Cataract and Refractive Surgery Annual Symposium in Chicago, Illinois.
The two multi-center studies evaluated the safety and efficacy of Durezol(TM) 0.05% compared to placebo dosed twice a day (BID) and four times a day (QID) beginning 24 hours after ocular surgery. The studies included 438 subjects who presented with an anterior chamber cell grade 2 (greater than or equal to 10 cells) or higher the day after surgery. The clinically and statistically significant findings demonstrated that Durezol(TM), at both the BID and QID dosing regimens, was superior to placebo in achieving the primary endpoint of proportion of subjects with an anterior chamber cell grade of 0 (less than or equal to 1 cell) on Day 8, with 30% of subjects in the BID group reaching Grade 0 versus 9% in the placebo group. Of the subjects in the QID group, 35% reached Grade 0 on Day 8. In addition, Durezol(TM) maintained superiority over placebo through the treatment period (Day 15), with 56% in the BID group and 63% in the QID group reaching Grade 0 versus 16% in the placebo group.
Further data from the presentation demonstrated that both the BID and QID dosing regimens were superior to placebo with regard to change from baseline in anterior chamber cell count at Day 8. The mean reduction in cell count for subjects in both the BID and QID groups was 19 cells and the mean reduction in the placebo group was 6 cells. In addition, the proportion of subjects who reached "clinical cure" (defined as anterior chamber cell count less than or equal to 5 and flare score of 0) at Day 15 was 73% in the BID group and 71% in the QID group versus 27% in the placebo group (p<0.0001).
Both the BID and QID groups were superior to placebo in eliminating pain as measured using the Visual Analogue Scale. Durezol(TM) was well tolerated with few treatment related adverse events. Mean intraocular pressure (IOP) for all study groups remained within the normal range throughout the study. Three subjects (3%) in the BID group, three subjects (3%) in the QID group, and two subjects (1%) in the placebo group met the criterion for a clinically significant rise in IOP, defined as an observed value of greater than or equal to 21 mm Hg and a change from baseline of 10 mm Hg. The analyses demonstrated comparable clinical efficacy and acceptable safety profiles for both the BID and QID dosing of Durezol(TM).
Sirion's New Drug Application for Durezol(TM) has been accepted for filing and granted priority review by the US Food and Drug Administration (FDA). The FDA has issued an action date of June 26, 2008 under the Prescription Drug User Fee Act. Sirion is currently conducting a Phase 3 trial with Durezol(TM) in patients with anterior uveitis and expects to have data by the end of 2008.
Durezol(TM) is the trademark of Sirion Therapeutics, Inc. and is currently under review by the U.S. Food and Drug Administration and has not yet been cleared as the trade name for commercial use.
About Post-Operative Inflammation
Over five million ophthalmic surgeries are performed each year in the United States. Post-operative inflammation is a common occurrence following these procedures, and if left untreated, can interfere with a patient's visual rehabilitation or lead to further complications. While the inflammation tends to be self-resolving, some cases can lead to other serious conditions if left untreated. As there is no way to predict which patients might develop inflammatory complications, doctors often prescribe steroids and/or NSAID drops to prevent it. Most often, inflammation lasts a relatively short time, though severe forms can persist for a longer period of time.
Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic steroid that has the potential to treat patients suffering from ocular inflammatory diseases, including post-operative inflammation. Durezol(TM) is a difluorinated derivative of prednisolone and has potent anti-inflammatory activity. The efficacy and safety of Durezol(TM) in ocular inflammatory diseases has been demonstrated in an extensive preclinical and clinical program in Japan.
About Sirion Therapeutics, Inc.
Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion's pipeline includes four compounds: difluprednate, a topical steroid for post-operative inflammation and uveitis; ganciclovir, a topical antiviral for herpetic keratitis; cyclosporine, a topical immunomodulator for dry eye; and fenretinide, a first-in-class oral vitamin A binding protein antagonist for geographic atrophy associated with dry AMD. In addition, Sirion has preclinical programs in back of the eye diseases and allergy. For more information, please visit http://www.siriontherapeutics.com