Navigation Links
Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA
Date:3/16/2009

Application Includes Data from a Comparative Trial in Anterior Uveitis

TAMPA, Fla., March 16 /PRNewswire/ -- Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) seeking market approval of Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% to treat endogenous anterior uveitis has been accepted for review. Durezol, developed and marketed by Sirion Therapeutics, was approved by the FDA in June 2008 for the treatment of post-operative inflammation and pain associated with ocular surgery.

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

"Uveitis is a debilitating and painful condition, and is one of the leading causes of blindness in the US," said Barry Butler, CEO of Sirion Therapeutics. "We are encouraged that the FDA is reviewing the application for our drug, which has the potential to treat this sight threatening condition."

The supplemental application includes data from several clinical studies, including one recently completed trial in the US of 90 patients with endogenous anterior uveitis that compared Durezol dosed QID to Pred Forte(R) (prednisolone acetate ophthalmic suspension) 1%, Allergan, dosed 8 times a day. In this study, Durezol was found to be non-inferior to Pred Forte in reducing the mean anterior chamber cell grade at Day 14 (mean cell grade reduction of 2.1 compared to 1.9). In addition, Durezol was numerically superior in almost every efficacy measure, including the reduction of anterior chamber flare and the reduction of signs and symptoms of inflammation. Notably, 12.5% of patients in the Pred Forte group were withdrawn from the trial due to lack of efficacy, while no patients were withdrawn from the Durezol group for this reason.

Two phase 3 clinical tr
'/>"/>

SOURCE Sirion Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Sirion Therapeutics Supports Ophthalmic Education
2. Sirion Therapeutics Acquires Worldwide License to Develop New Treatment for Ocular Diseases
3. Sirion Therapeutics Highlights Pivotal Trial Results of Durezol(TM) at the American Society of Cataract and Refractive Surgery Annual Symposium
4. Sirion Therapeutics Preclinical Studies: Two New Potential Advances in Treatment of Retinal Diseases to be Presented at ARVO
5. Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammation and Pain
6. Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes
7. Sirion Therapeutics Partners With Advanced Vision Research (TheraTears(R)) to Promote Products for Retinal and Meibomian Gland Health
8. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
9. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
10. PeriCor Therapeutics Announces Closing of Licensing Agreement for Acadesine with Schering-Plough Corporation
11. Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... 24, 2014 SRI International has been awarded ... Institute of Allergy and Infectious Diseases (NIAID), part of ... of potential therapies for HIV infection and AIDS. The ... and AIDS and the complications and opportunistic infections associated ... sexual transmission of HIV. According to ...
(Date:7/24/2014)... 2014 Deep Research Report on Global ... and in-depth research report on Potassium Sulphate ... information, including its definition, classification, application, and industry ... the international market analysis, including China’s domestic market ... environment & economic situation analysis, the influence of ...
(Date:7/24/2014)... July 24, 2014 1000 balances – ... input on customers’ weighing needs and expertly narrows down ... of balances, scales or even terminals. , First, ... smallest weight (or select readability instead) and define the ... additional selection criteria narrows down the list to models ...
(Date:7/24/2014)... July 24, 2014  Spherix Incorporated (SPEX) -- an ... monetization of intellectual property, today announced that the Company ... June 30, 2014 on Monday, August 18, 2014 for ... a.m. ET on Monday, August 18, 2014 to discuss ... the company,s CEO, Anthony Hayes . ...
Breaking Biology Technology:National Institute of Allergy and Infectious Diseases Awards SRI International Contract to Study New Therapies for HIV and AIDS 2National Institute of Allergy and Infectious Diseases Awards SRI International Contract to Study New Therapies for HIV and AIDS 3Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 2Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 3Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 4Spherix Schedules Shareholder Update Call 2
... Leum Software Solutions, Inc. has announced an exclusive ... Ascend retail management software package. Trek and Leum Software intend ... with additional tools and features to help them manage their ... ways to make our dealers more successful. In the future, ...
... but incorporate software-based components (such as microprocessors or microcontrollers) ... importance of protecting that software. The software may not ... of the product, but a feature nonetheless and a ... ,For example, many vehicles, such as motorcycles, trucks and ...
... - To complement the two- and four-port Ethernet cards ... has released software for Apple G4 and G4 servers ... with more bandwidth. , ,The company is the first to ... Mac platforms. In March, it expanded from the G5 to ...
Cached Biology Technology:Beyond the screws and gears: Protecting your products by protecting your software 2Small Tree boosts bandwidth for Apple G4 and G5 servers 2
(Date:7/25/2014)... The routine use of a molecular testing panel ... performing the correct initial surgery for patients with ... University of Pittsburgh Cancer Institute (UPCI), partner with ... Multidisciplinary Thyroid Center and other diagnostic testing agencies, ... initial surgery by 30 percent, according to the ...
(Date:7/24/2014)... Scientists at The New York Stem Cell Foundation ... creating a viable cell replacement therapy for multiple ... For the first time, NYSCF scientists generated induced ... of patients with primary progressive multiple sclerosis and ... these stem cells into becoming oligodendrocytes, the myelin-forming ...
(Date:7/24/2014)... 24, 2014 /PRNewswire-iReach/ -- The Geneva Healthcare Suite, an ... has cut emergency room wait times by an average ... Medical Center, according to a recent study published in ... are using the suite to access data from incoming ... "Using Geneva,s technology platform we have been ...
Breaking Biology News(10 mins):Test increases odds of correct surgery for thyroid cancer patients 2Test increases odds of correct surgery for thyroid cancer patients 3NYSCF scientists one step closer to cell therapy for multiple sclerosis patients 2UC San Diego Medical Center Cuts Average ER Wait Time by 92 Minutes using the Geneva Healthcare Suite 2UC San Diego Medical Center Cuts Average ER Wait Time by 92 Minutes using the Geneva Healthcare Suite 3
... ON, July 19, 2013 Kidney patients who take calcium ... 22 per cent higher risk of death than those who ... by Women,s College Hospital,s Dr. Sophie Jamal. The study, ... the long-time practice of prescribing calcium to lower phosphate levels ...
... This news release is available in German . ... of text, the brain sends commands to arms and fingers to tap ... transfer this information as electrical pulses that trigger muscles to move. The ... along the spinal cord. For a long time, scientists assumed that ...
... media has expanded to reach an unlikely new target: ... Technology (NIST) have created networks of molecular data similar ... search would allow Facebook users to find all their ... NIST-designed networks could help scientists rapidly sift through enormous ...
Cached Biology News:Calcium linked to increased risk of heart disease and death in patients with kidney disease 2Haste and waste on neuronal pathways 2Haste and waste on neuronal pathways 3Haste and waste on neuronal pathways 4Facebook for molecules 2Facebook for molecules 3
... GCpro Taq DNA Polymerase is a ... advantages for all PCR applications. GCpro Taq ... clone expressed in E. coli, containing the ... The enzyme includes a highly processive 5'-3' ...
Ps-Aeruginosa (IgG) -Ab EIA Sample Size: 100 l...
...
Automated -80° C sample library for microplates and cryotube racks in SBS format; for integration into automated processes....
Biology Products: