Navigation Links
Sirion Therapeutics Announces Positive Phase III Results for Difluprednate
Date:10/25/2007

- Data Support NDA Submission -

TAMPA, Fla., Oct. 25 /PRNewswire-FirstCall/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced positive preliminary results from its Phase III difluprednate (ST-601) program, which evaluated the steroid's potential to rapidly resolve inflammation in the eye following ocular surgery.

"We are very pleased with the data that demonstrate difluprednate's potential as a potent, well-tolerated steroid treatment for post-operative inflammation," said Dr. Roger Vogel, Sirion's Chief Medical Officer. "Based on these data, Sirion is moving forward with its plans to submit a New Drug Application to the FDA."

The Phase III program consisted of two multi-center, randomized, double- masked studies that compared the safety and efficacy of difluprednate 0.05% to placebo, dosed two (BID) or four (QID) times daily beginning 24 hours after surgery. The studies included 439 subjects who presented with Grade 2 (an inflammatory cell count greater than or equal to 10) or higher the day after surgery. Inflammation was measured by the number of cells in the anterior chamber of the eye with a Grade 0 equaling less than or equal to one cell. The primary efficacy endpoint measured the proportion of subjects whose inflammation reached Grade 0 at Day 8.

Both difluprednate dosing regimens were superior to placebo at the primary endpoint, reaching high statistical significance at Day 8 and maintaining superiority through both the treatment period (Day 15) and the tapering period (Day 29). At Day 15, 56% of subjects on the BID regimen reached Grade 0 compared to 16% in the control group (p<0.0001). Of the subjects on the QID regimen, 63% reached Grade 0 at Day 15. This was also statistically significant when compared to placebo, but not clinically different than the BID regimen. In addition, both difluprednate groups were statistically better than placebo in eliminati
'/>"/>

SOURCE Sirion Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Sirion Therapeutics Announces Clinical Data to be Presented at the 2007 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
5. CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
6. GTC Biotherapeutics to Webcast Corporate Presentation at the C.E. Unterberg, Towbin Emerging Growth Life Opportunities Conference
7. Fat Kills Cancer: Turning Stem Cells from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
8. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
9. Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
10. Pieris Progresses Development of its Proprietary Biotherapeutics Platform: Successful Demonstration of Dual Targeting With Duocalin(R) Technology
11. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Dec. 24, 2014 /PRNewswire/  -- Tianyin Pharmaceutical Inc. ... company that specializes in the patented biopharmaceutical, modernized ... pharmaceutical ingredients (API) released unaudited preliminary financial results ... Fiscal Year 2015 Ended September 30, ... million compared with $14.7 million in 1Q14 with ...
(Date:12/24/2014)... -- The International Trade Commission (ITC) issued its final decision in ... a notice issued on December 23, the ITC ruled in ... humidifier was invalid. BMC President, James Xu ... excited with the ITC,s decision in this case. This victory ... the very beginning on the key patents in the case. ...
(Date:12/24/2014)... FARMINGTON, Conn. , Dec. 24, 2014 ... a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics ... medical need and commercial potential, today announced that ... 2,050,000 shares of its common stock and Series ... common stock.  Funds under the management of QVT ...
Breaking Medicine Technology:TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 2TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 3TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 4TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 5TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 6TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 7TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 8TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 9TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 10TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 11TPI Presents Unaudited Preliminary First Quarter Fiscal Year 2015 Financial Results 12ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 3Palatin Completes $20 Million Equity and $10 Million Debt Financings 4
... SEATTLE, Jan. 31, 2012 /PRNewswire-iReach/ -- Today ... the launch of new last mile postal service delivery ... software. In addition to existing support of multiple global ... cost-effective delivery capabilities to businesses and residences in over ...
... 2012 Vystar Corporation (OTCBB: VYST), the exclusive ... third US and first Chinese patent for its ... five issued patents in the US and abroad that relate ... (Logo: http://photos.prnewswire.com/prnh/20100203/CL48049LOGO ) The new ...
Cached Medicine Technology:Enroute Adds Last Mile Postal Service Delivery Services 2Enroute Adds Last Mile Postal Service Delivery Services 3Vystar® Corporation Receives its Third US Patent and First Chinese Patent for Vytex® Natural Rubber Latex 2Vystar® Corporation Receives its Third US Patent and First Chinese Patent for Vytex® Natural Rubber Latex 3
(Date:12/24/2014)... York (PRWEB) December 24, 2014 ... ) that allege the blood thinner caused life-threatening ... outlined a leadership structure for the proceeding, Bernstein ... December 17th, the Court plans to select lawyers ... and also plans on appointing a Plaintiffs’ Steering ...
(Date:12/24/2014)... 2014 Mike Billings , PT, ... Derek Fenwick, PT, MBA, GCS, Director of Professional ... from the passing of the Improving Medicare Post-Acute ... this taping of the Infinicast, the two leaders discuss ... Social Security Act to standardize post-acute assessment data for ...
(Date:12/24/2014)... -- Hepatitis C infection does not contribute to mental decline ... Treatment advances have made it possible for people with HIV ... problems, mood swings and other types of mental impairment as ... long-term infections with other viruses -- a common problem in ... the prime suspects has been the hepatitis C virus, which ...
(Date:12/24/2014)... HealthDay Reporter WEDNESDAY, Dec. ... to start smoking or drinking with each additional symptom ... disorder, new research suggests. "Our findings underscore ... substance use as [these] children approach adolescence," said study ... Research Group, which is part of Cincinnati Children,s Hospital. ...
(Date:12/24/2014)... (PRWEB) December 24, 2014 For chic ladies, ... year. As a part of their Holiday Wish List, ... highlight as perfect ways to accent ladies’ holiday wardrobe by ... Ladies should be all over the discount of 80% off, ... and ready to ship. The company’s chic wedding dresses are ...
Breaking Medicine News(10 mins):Health News:Court Overseeing Federal Xarelto Lawsuits Issues Coordination Order, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal Xarelto Lawsuits Issues Coordination Order, Bernstein Liebhard LLP Reports 3Health News:Latest Episode of Infinicast Features Infinity Rehab President Discussing IMPACT Act of 2014 and Changes for Post-Acute Therapy Providers in 2015 2Health News:Hepatitis C Infection Isn't Related to HIV Brain Woes: Study 2Health News:ADHD May Raise Teens' Odds for Smoking, Drinking 2Health News:ADHD May Raise Teens' Odds for Smoking, Drinking 3Health News:Angeldress.co.uk Starts Its Big Sales by Offering Various Kinds of Cheap Clothes and Fashion Accessories 2
... medications are at an increased risk of falling in the ... dose increase of their current drug, according to a new ... an affiliate of Harvard Medical School., Published online in the ... that nursing home residents have a fivefold increased risk of ...
... in California hospitals to similar hospitals in the U.S. ... Pennsylvania School of Nursing have found that controversial legislation ... hospital staffing mix, not fewer as feared. , ... staffing levels. However, mindful of the ongoing nurse shortage ...
... July 15 (HealthDay News) -- Injection drug users have ... what types of drugs they use, according to a ... higher rates of abuse, dependence and other physical and ... programs specialize their care to target these high-risk individuals. ...
... of consent forms provided to volunteers for HIV/AIDS research ... risks and benefits has found that the forms were ... complex enough to hinder full understanding, according to bioethicists ... of 124 informed-consent documents for U.S. government-sponsored, multinational HIV/AIDS ...
... Rome (July 15, 2011): The Lancet , a leading ... the critical role of expanding access to HIV treatment under ... , The publication of the editorial comment coincides with ... Treatment and Prevention (IAS 2011) taking place in Rome, Italy ...
... An international team of researchers has identified two genetic regions ... Restless legs syndrome is a condition in which people experience ... only by movement. One of the most common neurological diseases, ... and even depression. In the new study, scientists ...
Cached Medicine News:Health News:Nursing home residents at heightened risk of falling in the days following 2Health News:California nurse staffing 2Health News:Injection Drug Users Most in Need of Treatment, Study Says 2Health News:Informed-consent forms should be shortened, simplified, Johns Hopkins bioethicists confirm 2Health News:Informed-consent forms should be shortened, simplified, Johns Hopkins bioethicists confirm 3Health News:Roll out treatment as prevention now to stop HIV and AIDS 2
... comprehensive line of pregnancy tests including rapid ... convenient one-step stick and cassette formats. The ... Easy HCG is a 25 mIU urine ... HCG II provides 25mIU sensitivity for ...
... Wampole Laboratories offers a comprehensive line ... for serum and urine in convenient one-step ... offers 2 testing options. Clearview Easy HCG ... a convenient stick format. Clearview HCG ...
... hemolyzed preparation of whole blood is mixed ... binding cation-exchange resin. During this time, HbAo ... period. a filter separator is used to ... which contains glycohemoglobin. The percent glycohemoglobin is ...
... is the main storage protein for iron. ... shell (apoferritin) composed of heavy and light ... iron oxide and phosphate [1]. Ferritin is ... other body tissues, with major concentrations found ...
Medicine Products: