Navigation Links
Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
Date:2/22/2011

nt analysis was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab.  A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab.  The ocular adverse events were balanced across all treatment groups in both studies.  There were no notable differences in non-ocular adverse events among the study arms.

About the VIEW Program The VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program consists of two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD).  The VIEW 1 study, which randomized 1217 patients, is being conducted in the United States and Canada by Regeneron under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration.  The VIEW 2 study, which randomized 1240 patients, is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare.  The study designs are essentially identical.  The primary endpoint evaluation was conducted at 52 weeks.

In each of the studies, VEGF Trap-Eye was evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5 mg monthly, 2.0 mg monthly, or 2.0 mg every two months (following three monthly loading doses), as compared with intravitreal ranibizumab administered 0.5 mg every month during the first year of the studies.  

The primary endpoint of these non-inferiority studies was the proportion of patients treated with VEGF Trap-Eye who maintained visual acuity at the end of one year, compared to ranibizumab patients.  Visual acuity was measured as a score based on the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used i
'/>"/>

SOURCE Regeneron Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
5. Regeneron Reports Third Quarter 2009 Financial and Operating Results
6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration
7. Regeneron Announces Presentation at the Deutsche Bank 2009 Biotech Boston Confab
8. BioMed Realty Trust Signs New Lease With Regeneron Pharmaceuticals for 131,000 Square Feet at Landmark
9. Regeneron Announces Presentation at the Morgan Stanley Global Healthcare Conference
10. Regeneron Announces Presentation at the UBS Global Life Sciences Conference
11. Regeneron Announces Panel Discussion at Citis 5th Annual Biotech Day
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... , Dec. 24, 2014 Soligenix, Inc. ... biopharmaceutical company developing products that address unmet medical ... biodefense, announced today that on December 24, 2014 ... The Company raised approximately $2.3 million ... to use the net proceeds from the offering ...
(Date:12/24/2014)... and FARMINGTON, Conn. , Dec. ... MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific ... significant unmet medical need and commercial potential, today ... placement of 2,050,000 shares of its common stock ... of its common stock.  Funds under the management ...
(Date:12/24/2014)... Wash. , Dec. 23, 2014  Advanced ... development company engaged primarily in the development of ... therapeutic applications, today announced that it has filed ... Food and Drug Administration ("FDA") for marketing clearance ... Section 513(f)(2) of the U.S. Food, Drug and ...
Breaking Medicine Technology:Soligenix Announces Closing of Public Offering of Units 2Soligenix Announces Closing of Public Offering of Units 3Palatin 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 4Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel(TM) Device 2Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel(TM) Device 3
(Date:12/25/2014)... Recently, LunaDress.co.uk has updated its blog to provide professional ... all of the models at LunaDress.co.uk come with big discounts, up ... wedding veil can turn out to be a most exciting memory ... can always bring surprise to a wedding. On the updated fashion ... choose veils for a big day . , Going out with ...
(Date:12/25/2014)... (HealthDay News) -- Among early stage breast cancer patients ... of one percent will eventually develop leukemia as a ... The finding comes from a review of more than ... and it suggests that the risk for developing treatment-related ... previously thought. "The frequency of bone marrow cancers ...
(Date:12/25/2014)... 25, 2014 “ SmileStix ” was featured ... the latest and coolest mobile applications on the iOS, Android, ... host of NewsWatch, conducted the app review and shared with ... personal stickers. , The old saying goes, “A picture says ... words that can describe a single image, because each picture ...
(Date:12/25/2014)... Parker & Sons, Inc. an industry leader ... quality regarding heating, cooling and plumbing services in the ... the “Queen of Clean” for impressive contractor services in ... over the years for providing outstanding quality customer service ... services for both homeowners and businesses. Linda Cobb, known ...
(Date:12/24/2014)... TX (PRWEB) December 24, 2014 Connie ... specialist and functional medicine advocate with 30 years of ... trial to evaluate the health benefits of dietary detoxification. ... with new participants following excellent results from test patients ... When asked to explain her interest in conducting the ...
Breaking Medicine News(10 mins):Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 3Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 3Health News:Connie Casad, MD, Now Accepting Test Participants for January Dietary Detoxification Study 2Health News:Connie Casad, MD, Now Accepting Test Participants for January Dietary Detoxification Study 3
... issue of American Journal of Preventive Medicine says that there ... ,These conclusions were arrived at by researchers at ... Centers for Disease Control and Prevention. They monitored data of ... Factor Surveillance System survey. This particular survey covered 22 states ...
... appearing in the online journal Cancer says that elderly white ... to develop full blown melanoma regardless of their exposure to ... study found that women in the age group of 50 ... carcinoma or squamous cell carcinoma of the skin, had a ...
... attempt to rapidly eliminate milder strains of avian influenza virus ... been proposed to broaden the target of the European Union ... been taken by agricultural ministers of the 25 different countries ... the proposal, it was agreed to boost the currently existing ...
... into the oral HIV tests which have given false results. ... California and New York health centers. The rapid OraQuick Advance ... minutes. The test had gained popularity as blood samples are ... ,Complaints are being investigated by officials belonging to ...
... Hickok, neuroscientist, professor of cognitive sciences at the University ... The National Institute of //Deafness and Other Communication Disorders ... Health ($2.4 million for 5 years). ,This ... brain converts sound waves into meaningful language. ...
... health hospitals are flooded with patients with psychiatric disorders. The ... 12% in the past 4 years. ,This ... health facilities. ,According to the Australian Institute of ... specialized psychiatric hospitals decreased by 5%. ,But the ...
Cached Medicine News:Health News:Detection of Weak strains of bird flu virus – Target of European Unio 2Health News:$2.4 Million Grant To Unravel The Mystery Of Language Recognition. 2Health News:Community hospitals inundated with Psychiatric care cases (12%) 2
... Grade PRODUCT SPECIFICATIONS Form: Granular, free-flowing powder EEO(-m r ... Point (3%): less than or equal to 35.5C ... 80C Gel Strength (1.5%): greater than or equal ... greater than or equal to 1500 gm/cm 2 ...
... sulfate (SO 4 ) ≤ 6000 mg/kg Cation traces: ... ≤ 10 mg/kg Cr ≤ 10 mg/kg Cu ≤ ... mg/kg Mg ≤ 10 mg/kg Mn ≤ 10 mg/kg ... ≤ 10 mg/kg Zn ≤ 10 mg/kg Special ...
Application: Capable of separating DNA fragments of 50 to 1000 bp on a 3% gel Solubility: water 15 mg/mL, clear, colorless, hot Special grade: for molecular biology Suitab tst: electrophoresis te...
Inquire...
Medicine Products: