Navigation Links
Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol(TM) in the Treatment of Postoperative Ocular Inflammation
Date:2/27/2008

TAMPA, Fla., Feb. 27 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for Durezol(TM) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Sirion Therapeutics is seeking approval from the FDA for its investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080220/CLW064LOGO )

Priority review is granted by the FDA to those drugs that have the potential to provide a significant improvement compared to marketed products. This designation results in a review period of six months from the date of receipt of the NDA. The FDA has issued an action date of June 26, 2008 under the Prescription Drug User Fee Act (PDUFA).

Data from two Phase 3 clinical studies in post-operative inflammation will be presented at the American Society of Cataract and Refractive Surgery 2008 Symposium and Congress on Tuesday, April 8, 2008 at 8:32 am in room 176B at McCormick Place West in Chicago, IL.

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 http://www.siriontherapeutics.com.


'/>"/>
SOURCE Sirion Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Nektar Therapeutics Announces Fourth Quarter and Year-End 2007 Financial Results
2. Prime Therapeutics Introduces Efficiency Program to Help Employers Understand How to Most Effectively Spend Pharmacy Dollars
3. Hyperion Therapeutics Announces Enrollment of First Patient in Phase 2 Clinical Trial in Patients With Hepatic Encephalopathy
4. Oracle Healthcare Acquisition Corp. and Precision Therapeutics, Inc. Agree in Principle to Amend Merger Agreement to Reduce Consideration by 15%
5. Synvista Therapeutics to Present at the Roth 20th Annual OC Growth Stock Conference
6. Echo Therapeutics Announces Closing of Approximately $2.3 Million Private Financing
7. Transition Therapeutics Announces Second Quarter Fiscal 2008 Financial Results
8. DARA BioSciences, Inc. and Point Therapeutics, Inc. Announce Consummation of Merger
9. Protalix BioTherapeutics Appoints Professor Roger D. Kornberg to Board of Directors
10. Transition Therapeutics to Hold Conference Call on Second Quarter Fiscal 2008 Financial Results on Tuesday, February 12, 2008 at 5:00 P.M. EST
11. Nile Therapeutics Announces Dosing of First Heart Failure Patient in Phase Ib Study of CD-NP
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... ... January 16, 2017 , ... ... Dental Center, is currently offering complimentary consultations and financing for orthodontics for a ... for bite irregularities and learn about their orthodontic options. Walk-in, late-evening, Saturday, and ...
(Date:1/16/2017)... ... 2017 , ... Permobil has just completed the acquisition of ... systems has a well-earned reputation for premium quality, with a focus on fit ... in the custom seating business, which enjoys strong demand, and it complements Permobil’s ...
(Date:1/16/2017)... ... 16, 2017 , ... Atlanta-based incentive company Incentive Solutions ... wheelchair accessibility industry, BraunAbility . Incentive Solutions will provide BraunAbility a debit ... With this new incentive plan, BraunAbility plans to continue their tradition of excelling ...
(Date:1/16/2017)... (PRWEB) , ... January 16, 2017 , ... ... editor, attorney, science teacher, http://www.ageofautism.com/legal , Sharon Kleyne, America’s leading water ... Heckenlively to her nationally syndicated radio program, The Sharon Kleyne Hour Power of ...
(Date:1/16/2017)... ... 2017 , ... In 1985, the International Association of Eating ... an international multidisciplinary group of healthcare treatment providers and helping professions who treat ... mission at the grassroots level, iaedp launched MemberSHARE, an online peer community solely ...
Breaking Medicine News(10 mins):
(Date:1/16/2017)...  This report by Persistence Market Research examines ... the period 2016–2024. The primary objective of the ... to market opportunities in the global peripherally inserted ... the various dynamics that are expected to influence ... global peripherally inserted central catheters market over the ...
(Date:1/16/2017)... 16, 2017 Derek H. Potts , ... was recently appointed Liaison Counsel in California,s ... Xarelto cases. In this role, Potts was assigned to ... actively assist the Court and Co Lead Plaintiff,s Counsel. ... Adelman Jackson Fairchild & Wade and Ruth ...
(Date:1/16/2017)... ROCKVILLE, Md. , Jan. 16, 2017 /PRNewswire/ ... tomography (CT) systems market is valued at $4.9 ... applications for CT, coupled with an aging population ... incidence of chronic disease, is propelling the market ... report, Computed Tomography Markets , focuses on ...
Breaking Medicine Technology: