Navigation Links
Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
Date:4/27/2011

disease.  The incidence of ocular serious adverse events was higher in the sham group compared to the active treatment arm (8.8% vs 2.9%).

Regeneron intends to submit a regulatory application for marketing approval in CRVO in the U.S. in the second half of 2011, and Bayer HealthCare is planning to submit regulatory applications in Europe in 2012.

Detailed results of the GALILEO study will be presented at the EURETINA Congress in London in May, 2011.

About the Phase 3 CRVO Program

Patients in the COPERNICUS (Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) and the almost identical GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) studies received six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections.

Patients in both trials were randomized in a 3:2 ratio with 114 patients randomized to receive VEGF Trap-Eye and 73 randomized to the control arm in COPERNICUS and 104 patients randomized to receive VEGF Trap-Eye and 68 randomized to the control arm in GALILEO.  At the end of the initial six months, all patients randomized to VEGF Trap-Eye are dosed on a PRN (as needed) basis for another six months.  In the COPERNICUS trial, patients randomized to sham injections in the first six months were eligible to cross over to VEGF Trap-Eye PRN dosing in the second six months.  During the second six months of the studies, all patients are eligible for rescue laser treatment.  Visual acuity is 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 in research to measure visual acuity.

Phase 3 GALILEO Study Results

In the GALILEO study, 60.2 percent of patients receiving VEGF Trap-Eye 2mg monthly gained
'/>"/>

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

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Regeneron and Bayer Announce Start of Phase 3 Clinical Program in Diabetic Macular Edema
2. Regeneron Announces Presentation at the 10th Annual Needham Healthcare Conference
3. Sanofi-aventis and Regeneron Report Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer
4. Regeneron Announces March 2011 Investor Conference Presentations
5. Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
6. Regeneron Reports Full Year and Fourth Quarter 2010 Financial and Operating Results
7. Regeneron to Webcast Investor Briefing on VEGF Trap-Eye Clinical Program on Sunday, February 13th at 9 am ET
8. Regeneron Announces Presentation at the ISI Annual Conference
9. Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME)
10. Regeneron Schedules December 20, 2010 Teleconference and Webcast to Discuss Results of VEGF Trap-Eye Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and Phase 2 Study in Diabetic Macular Edema (DME)
11. Christine A. Poon Elected to Regeneron Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2014)... Oct. 1, 2014 The global high content ... by the ,Threat of Obsolescence, wherein technologies as well ... Pharmaceutical and biotechnology companies as well as academic and ... screening as a powerful research tool in drug discovery. ... segment in the high content screening market. In high ...
(Date:10/1/2014)...  Dyadic International, Inc. ("Dyadic") (OTCQX: DYAI), a ... used to develop and produce enzymes and other ... industrial enzymes industries, today announced the receipt of ... commercial scale production of Abengoa,s proprietary cellulase enzymes, ... Abengoa,s license agreement with Dyadic. ...
(Date:10/1/2014)... 2014 Trovagene, Inc., (NASDAQ:  TROV) a ... Eli Diamond , MD, Assistant Attending Neurologist ... clinical data from an ongoing study demonstrating the ... the determination of oncogene mutational status in cell-free ... were presented to both treating physicians and patients ...
Breaking Medicine Technology:High Content Screening Market by Instruments (Cell Imaging and Analysis System), by Applications (Primary and Secondary Screening, Target Identification and Validation, Toxicity Studies, Compound Profiling), Software & Services - Global Forecasts to 2High Content Screening Market by Instruments (Cell Imaging and Analysis System), by Applications (Primary and Secondary Screening, Target Identification and Validation, Toxicity Studies, Compound Profiling), Software & Services - Global Forecasts to 3Dyadic International Reports Licensing Payment For Commercial-Scale Production Of C1-Based Cellulase Enzymes 2Dyadic International Reports Licensing Payment For Commercial-Scale Production Of C1-Based Cellulase Enzymes 3Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium 2Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium 3Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium 4
... 19, 2011 /PRNewswire-Asia/ -- Winner Medical Group Inc. (Nasdaq: ... leading manufacturer of medical dressings, medical disposables and non-woven ... announced today that the Company will participate in Arab ... 27th, at the International Convention Exhibition Centre in Dubai, ...
... LAKE CITY, Jan. 18, 2011 TechniScan ... device company engaged in the development and commercialization of ... that it has signed a Product Development Agreement with ... $1.5 million. TechniScan and Womens3D will ...
Cached Medicine Technology:Winner Medical to Participate in Arab Health 2011, International Healthcare Exhibition, in Dubai 2Winner Medical to Participate in Arab Health 2011, International Healthcare Exhibition, in Dubai 3TechniScan Signs Agreement With Texas-Based Company to Co-Develop A New Version of Its Breast Imaging Device 2TechniScan Signs Agreement With Texas-Based Company to Co-Develop A New Version of Its Breast Imaging Device 3
(Date:10/2/2014)... October 02, 2014 USARAD Holdings ... and telemedicine solutions provider including its SecondOpinions.com® division, ... have joined its Executive Team as President & ... Brent Backhaus, USARAD’s new President and COO, is ... of progressively responsible experience in commercial-, medical- and ...
(Date:10/2/2014)... (PRWEB) October 02, 2014 Robins ... from the Associated Builders and Contractors (ABC) of ... at tonight’s banquet held at Sheraton Birmingham Hotel., ... Massachusetts, Healthcare $10 Million to $25 Million, Obelisk ... Dental Clinic, Federal Government $10 Million to $25 ...
(Date:10/2/2014)... Maureen Salamon HealthDay Reporter ... women with a neurotic personality style and prolonged stress ... new research suggests. Tracking 800 women over nearly ... most anxious, jealous and moody -- which they defined ... the risk of developing Alzheimer,s compared to women scoring ...
(Date:10/2/2014)... HealthDay Reporter WEDNESDAY, Oct. 1, 2014 (HealthDay ... reduced by breast-feeding. Nor will delaying the introduction of a ... help prevent celiac disease. Those are the conclusions ... New England Journal of Medicine . The new ... celiac disease if mothers breast-feed their babies and introduce gluten ...
(Date:10/1/2014)... researchers from the University of Adelaide have developed a ... of a good outcome from treatment - from their ... on a range of factors, including clinical symptoms, cognitive ... in the patient,s blood. , Speaking in the lead ... University,s Head of Psychiatry , Professor Bernhard ...
Breaking Medicine News(10 mins):Health News:Teleradiology and Telemedicine Pioneers Brent Backhaus and Lorna Backhaus Join USARAD Holdings, INC. & SecondOpinions.com® 2Health News:Teleradiology and Telemedicine Pioneers Brent Backhaus and Lorna Backhaus Join USARAD Holdings, INC. & SecondOpinions.com® 3Health News:Robins & Morton wins nine awards from Associated Builders and Contractors 2Health News:Jealous, Moody Women May Face Higher Alzheimer's Risk, Study Says 2Health News:Jealous, Moody Women May Face Higher Alzheimer's Risk, Study Says 3Health News:Infant's Early Diet Doesn't Change Celiac Disease Risk, Study Finds 2Health News:Infant's Early Diet Doesn't Change Celiac Disease Risk, Study Finds 3Health News:Predicting the future course of psychotic illness 2
... , TUESDAY, Jan. 4 (HealthDay News) -- Nearly 60 ... victims of violence, abuse or crime in the past year. ... happened. Researchers led by David Finkelhor of the University ... parents of children up to 9 years old in 2008. More ...
... Reporter , TUESDAY, Jan. 4 (HealthDay News) -- Common ... stem cell defect, a finding that could potentially lead ... study reveals. Researchers say they discovered that a ... stem cells turn into hair-producing progenitor cells. That defect, ...
... , TUESDAY, Jan. 4 (HealthDay News) -- The ... (arrhythmias) that can cause sudden death may be underestimated, ... healthy people without heart disease found detectable changes in ... to polluted air. The findings suggest that air ...
... Jan. 4 (HealthDay News) -- Levels of schooling may affect ... heart attack called acute ST-segment elevation myocardial infarction (STEMI), a ... of heart attack, STEMI occurs when the coronary artery is ... heart. In the new study, Dr. Rajendra H. ...
... Reporter , TUESDAY, Jan. 4 (HealthDay News) -- Simply measuring ... how many years they have left. In fact, a ... older people,s future life span about as well as taking ... disease. Walking speed may not be a perfect window ...
... YORK (Jan. 4, 2011) Researchers have produced a lasting anti-cocaine ... bits of the common cold virus with a particle that mimics ... published Jan. 4 in the online edition of Molecular Therapy ... researchers say this novel strategy might be the first to offer ...
Cached Medicine News:Health News:Survey Finds Much Victimization of Children Goes Unreported 2Health News:Stem Cell Defect Might Help Spur Common Baldness 2Health News:Stem Cell Defect Might Help Spur Common Baldness 3Health News:Higher Education May Benefit Some Heart Attack Patients 2Health News:Fast Walkers May Have More Years Ahead of Them 2Health News:Fast Walkers May Have More Years Ahead of Them 3Health News:Vaccine blocks cocaine high in mice 2Health News:Vaccine blocks cocaine high in mice 3
... a broad selection of tip ... wide variety of ophthalmic procedures. ... packaged sterile, complete with a ... in the "off " position ...
... Accu-Temp Cauteries provide a broad ... cauterization in a wide variety ... use cautery is packaged sterile, ... to lock switch in the ...
... Cauteries provide a broad selection of ... wide variety of ophthalmic procedures. Each ... complete with a safety cap to ... position when not in use, and ...
... Cauteries provide a broad selection of ... wide variety of ophthalmic procedures. Each ... complete with a safety cap to ... position when not in use, and ...
Medicine Products: