Navigation Links
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 /PRNewswire/ -- 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.

(Logo: )

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.

About Durezol(TM)

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

SOURCE Sirion Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Sirion Therapeutics Acquires Worldwide License to Develop New Treatment for Ocular Diseases
2. Sirion Therapeutics Supports Ophthalmic Education
3. Alba Therapeutics Announces Appointment of Bruce A. Peacock as its Chief Executive Officer
4. Amsterdam Molecular Therapeutics to Appoint George Morstyn to Supervisory Board
5. DiObex Announces Presentation of Scientific Poster at Annual Meeting of American Society for Clinical Pharmacology and Therapeutics
6. ImaRx Therapeutics Reports Business Update and Financial Results for Fourth Quarter and Full Year 2007
7. Mercury Therapeutics Patents Filed
8. Cell Therapeutics, Inc. Announces Filing of Form 10-K
9. Vicus Therapeutics Announces Participation at 15th International Molecular Medicine Tri-Conference
10. TorreyPines Therapeutics Reports Fourth Quarter and Full Year 2007 Financial Results and Highlights
11. Amsterdam Molecular Therapeutics to Appoint Alexander Ribbink to Supervisory Board
Post Your Comments:
(Date:6/27/2016)... 27, 2016  Liquid Biotech USA ... of a Sponsored Research Agreement with The University ... (CTCs) from cancer patients.  The funding will be ... correlate with clinical outcomes in cancer patients undergoing ... then be employed to support the design of ...
(Date:6/24/2016)... ... ... Researchers at the Universita Politecnica delle Marche in Ancona combed medical journal articles ... findings are the subject of a new article on the Surviving Mesothelioma website. ... blood, lung fluid or tissue of mesothelioma patients that can help point doctors to ...
(Date:6/23/2016)... , June 23, 2016 A person commits ... the crime scene to track the criminal down. ... U.S. Food and Drug Administration (FDA) uses DNA evidence to ... Sound far-fetched? It,s not. The FDA has ... to support investigations of foodborne illnesses. Put as simply as ...
(Date:6/23/2016)...   EpiBiome , a precision microbiome engineering company, ... financing from Silicon Valley Bank (SVB). The financing will ... its drug development efforts, as well as purchase additional ... has been an incredible strategic partner to us – ... would provide," said Dr. Aeron Tynes Hammack , ...
Breaking Biology Technology:
(Date:6/3/2016)... , June 3, 2016 ... von Nepal hat ... Lieferung hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, Registrierung ... in der Produktion und Implementierung von Identitätsmanagementlösungen. ... Ausschreibung im Januar teilgenommen, aber Decatur wurde ...
(Date:6/2/2016)...   The Weather Company , an IBM Business (NYSE: ... capability in which consumers will be able to interact with ... via voice or text and receive relevant information about the ... Marketers have long sought an advertising solution that can create ... relevant and valuable; and can scale across millions of interactions ...
(Date:6/1/2016)... -- Favorable Government Initiatives Coupled With Implementation ... to Boost Global Biometrics System Market Through 2021  ... " Global Biometrics Market By Type, By End ... - 2021", the global biometrics market is projected to ... growing security concerns across various end use sectors such ...
Breaking Biology News(10 mins):