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:1/14/2014)... InformEx, North America,s leading business ... hold the 30 th edition of its annual conference ... from January 21-24. (Logo: http://photos.prnewswire.com/prnh/20131028/NY05330LOGO-a ) ... chemical and specialty chemical companies will take part in the ...
(Date:1/14/2014)... Dynamic Healthcare Services, Inc. ("DHS"), a portfolio company of ... Home Medical Equipment, Inc. ("Progressive") of Clarion, PA ... acquisition were not disclosed. Progressive is a ... range of sleep, mobility, and respiratory products to customers in ...
(Date:1/14/2014)... 2014 Animal Emergency Critical Care, a LifeCentre partner practice, located ... is the first in Loudoun County ... Dr. Susan M. Barnes , Medical Director, is a well-seasoned ... Cole Taylor , are avid scuba divers. "As altitude skiers ...
Breaking Medicine Technology:Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3Hyperbaric Veterinary Medicine (hvm) Announces Animal Emergency Critical Care Installs A Small Animal Hyperbaric Chamber 2
(Date:4/17/2014)... new study has found that India,s shocking rates of ... farmers who are clinging to tiny smallholdings less ... crops, such as cotton and coffee, that are highly ... a range of previous case studies that point to ... following the ,liberalisation, of the nation,s economy during the ...
(Date:4/17/2014)... Giving patients adrenaline after they suffer a cardiac arrest ... of surviving long-term, according to new research conducted at ... who have a cardiac arrest get adrenaline, which has ... decades," said Dr. Steve Lin, an emergency physician and ... in medical treatment, long-term survival rates of patients who ...
(Date:4/17/2014)... its status as the leading weapon against the deadly ... with new research indicating it simply needs to be ... of the cheap anti-malarial drug chloroquine in treating and ... more than half a million people each year around ... developed resistance to chloroquine, but research carried out at ...
(Date:4/16/2014)... of the embryo. It begins as a glob of identical ... become the cells of our lungs, muscles, nerves and all ... a feat of reverse tissue engineering, Stanford University researchers have ... cells to proliferate and transform into all of the specialized ...
(Date:4/16/2014)... Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced today that ... in solid tumors, including long-term patient follow-up, have been ... Issue 232). The data demonstrate robust antibody and T ... with very advanced cancers and suggest that CDX-1401 may ...
Breaking Medicine News(10 mins):Health News:New evidence of suicide epidemic among India's 'marginalized' farmers 2Health News:New evidence of suicide epidemic among India's 'marginalized' farmers 3Health News:Adrenaline does little to increase patient's survival after cardiac arrest 2Health News:Scientists find new way to fight malaria drug resistance 2Health News:Stanford scientists develop 'playbook' for reverse engineering tissue 2Health News:Stanford scientists develop 'playbook' for reverse engineering tissue 3Health News:Celldex's Phase 1 study of CDX-1401 published in Science Translational Medicine 2Health News:Celldex's Phase 1 study of CDX-1401 published in Science Translational Medicine 3Health News:Celldex's Phase 1 study of CDX-1401 published in Science Translational Medicine 4
... involved in cancer, aging , , MONDAY, Sept. 1 (HealthDay ... active region of telomerase, an enzyme involved in both ... repeats of a short DNA sequence to the ends ... damage and loss of genetic information during cell division. ...
... appear to be at higher risk for psychiatric ... children, according to a report in the September ... one of the JAMA/Archives journals. In addition, low-birth-weight ... to have attention problems than suburban low-birth-weight children. ...
... the East coast distribute formula sample packs to new ... concerned about the potential for distributing these packs to ... September issue of Archives of Pediatrics & Adolescent ... practice is changing significantly. , "Packaged as smart diaper ...
... found it predicted outcome months after patient went home ... who sleep during the day while in rehabilitation have ... study, which was expected to be published in the ... the sleeping patterns and other predictors of recovery (e.g., ...
... drug from a biodegradable polymer , , MONDAY, Sept. 1 ... artery-opening, drug-eluting stents appears equally effective as older models ... study shows. , Stents are tiny mesh tubes inserted ... medicines that help prevent reclosure. The latest form of ...
... of a former U.S. soldier whose traumatic brain injuries (TBIs) were ... years after his discharge. The soldier, who suffered several concussions during ... and hearing/visibility issues on a daily basis. , ... ...
Cached Medicine News:Health News:Secrets of Telomerase Revealed 2Health News:Study examines relationship between low birth weight and psychiatric problems in children 2Health News:Hospitals provide formula sample packs while medical organizations encourage breastfeeding 2Health News:Daytime Sleeping Linked to Poor Recovery in Older Patients 2Health News:New Type of Stent Appears Safe, Effective 2Health News:LegalView Reports Details of War Veteran Brain Injuries Overlooked By Officials for Years 2Health News:LegalView Reports Details of War Veteran Brain Injuries Overlooked By Officials for Years 3Health News:LegalView Reports Details of War Veteran Brain Injuries Overlooked By Officials for Years 4
...
...
...
... The KyphX Xpander Inflatable Bone Tamp is ... cancellous bone while resisting puncture. Like an ... X-ray image guidance because it is inflated ... contrast medium increases the balloon volume. The ...
Medicine Products: