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:7/22/2014)... 2014 Galmed Pharmaceuticals Ltd. (Nasdaq: ... the development and commercialization of a once-daily, oral therapy ... announced today that the U.S. Food and Drug Administration, ... IND, application.  Such clearance will permit Galmed to conduct ... the United States for the treatment ...
(Date:7/22/2014)... , July 22, 2014 /PRNewswire-iReach/ -- Reproductive Medicine ... New York ), a nationally and internationally-recognized leader ... requiring reproductive assistance, is pleased to announce a new ... Compassionate Care Programs to recognize the sacrifices made by ... The Compassionate Corps Program will allow qualifying veterans and ...
(Date:7/22/2014)... a privately-held medical products and technologies company, today announced ... financial officer of the company, effective July 22, 2014. ... and chief financial officer of Elan Corporation, a ... part of a senior team that helped build significant ... Perrigo, a pharmaceutical manufacturer, in December 2013. ...
Breaking Medicine Technology:Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders 2Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders 3Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders 4Reproductive Medicine Associates of New York Collaborates with EMD Serono to Offer Treatment Assistance to Eligible Veterans and their Spouses 2Reproductive Medicine Associates of New York Collaborates with EMD Serono to Offer Treatment Assistance to Eligible Veterans and their Spouses 3ConvaTec Names Nigel Clerkin Chief Financial Officer 2
... May 24, 2011 Framingham-based Boston Heart Lab announced ... Diagnostics. The company launched its new name and logo ... May 19-22 in New York City. (Logo: ... reputation every day as a high-science, high-service company that,s ...
... NEW YORK, May 24, 2011 Reportlinker.com ... is available in its catalogue: ... http://www.reportlinker.com/p0284639/Triple-Analysis-Lymphoma-Melanoma-and-Peptides.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology ... cancer drug development strategies in both Lymphoma ...
Cached Medicine Technology:Boston Heart Lab Changes Name to Boston Heart Diagnostics 2Boston Heart Lab Changes Name to Boston Heart Diagnostics 3Reportlinker Adds Triple Analysis: Lymphoma, Melanoma and Peptides 2Reportlinker Adds Triple Analysis: Lymphoma, Melanoma and Peptides 3Reportlinker Adds Triple Analysis: Lymphoma, Melanoma and Peptides 4Reportlinker Adds Triple Analysis: Lymphoma, Melanoma and Peptides 5
(Date:7/22/2014)... 2014 The Pennsylvania judge overseeing ... in the Philadelphia Court of Common Pleas ... in cases alleging the medication caused plaintiffs to ... reports. In an Order dated July 18, 2014, ... to certify the matter for an immediate appeal ...
(Date:7/22/2014)... -- One of the largest studies ever conducted into ... 83 new sites on chromosomes that harbor inherited genes ... international team of researchers, now bring the total number ... 108. Although these schizophrenia-associated genes aren,t specific ... who will or will not develop the illness, researchers ...
(Date:7/22/2014)... 2014 CarePoint Health is pleased to announce ... President of the medical staff at Bayonne Medical Center. The ... President, as voted on by the physicians on staff. The ... in relation to the administration at Bayonne Medical Center. Dr. ... to work to make the Medical Center the best it ...
(Date:7/22/2014)... from the Edusei Foundation was greatly appreciated by the staff ... engineering, such assistance tends to etch good memories of family ... a sense of family to them, which the Edusei Foundation ... donated various amounts of; milk, soap, frytol, sugar, malt milk, ... Ghana established the Kumasi Children’s Home in 1965 to provide ...
(Date:7/22/2014)... July 22, 2014 Hospitals ... survey was conducted by Hospitals & Health ... Association, AT&T, CareTech Solutions, The College of ... Most Wired list recognizes hospitals for successful ... evaluates hospitals in four focus areas: business ...
Breaking Medicine News(10 mins):Health News:Risperdal Lawsuit News: Pennsylvania Judge Won’t Reconsider Denial of Punitive Damages for Risperdal Gynecomastia Plaintiffs, Bernstein Liebhard LLP Reports 2Health News:Risperdal Lawsuit News: Pennsylvania Judge Won’t Reconsider Denial of Punitive Damages for Risperdal Gynecomastia Plaintiffs, Bernstein Liebhard LLP Reports 3Health News:Risperdal Lawsuit News: Pennsylvania Judge Won’t Reconsider Denial of Punitive Damages for Risperdal Gynecomastia Plaintiffs, Bernstein Liebhard LLP Reports 4Health News:Gene Discoveries Could Shed New Light on Schizophrenia 2Health News:Dr. Howard Levine Elected President of the Medical Staff at Bayonne Medical Center 2Health News:Edusei Foundation Donates Food and Needed Items to Kumasi Children’s Home in Ashanti Region of Ghana 2Health News:Healthline Systems’ Clients Honored Among Most Wired for 2014 2Health News:Healthline Systems’ Clients Honored Among Most Wired for 2014 3Health News:Healthline Systems’ Clients Honored Among Most Wired for 2014 4
... fevers (FHFs) such as those caused by the Ebola ... have the support and trust of local communities, according ... of the Journal of Infectious Diseases as part of ... exist of the experiences of outbreak control teams, and ...
... growing demand for reconciling medications across the healthcare continuum ... ... of CPOE, SAN BRUNO, Calif., Oct. 29 First ... Med Knowledge Base(TM), a computerized physician order entry,(CPOE)-ready drug database ...
... Company Expands Support to 75 Percent of Military ... CACI International,Inc (NYSE: CAI ) announced today ... task order contract to support the Military Health ... the award, CACI will,supply information assurance solutions to ...
... Group ... Chicago, DALLAS, Oct. 29 Affiliated Computer Services,Inc. ... meet the changing healthcare needs of retirees, including,millions of ... Informed Health Navigator is an innovative product that analyzes,retirees, ...
... detection and treatment recommendations, , , MONDAY, Oct. 29 ... it easier for pediatricians to spot and begin ... the American Academy of Pediatrics has released two ... these conditions. , "Pediatricians are the front line" ...
... Management Diary Provides Easy Way to Record, Track and Share Health ... ... Oct. 29 ReliefInsite,( http://www.reliefinsite.com ) today unveiled a new release ... way,for companies and developers to integrate with the Facebook website. With,more ...
Cached Medicine News:Health News:Agencies must win trust of locals to contain Marburg and Ebola outbreaks 2Health News:Agencies must win trust of locals to contain Marburg and Ebola outbreaks 3Health News:Agencies must win trust of locals to contain Marburg and Ebola outbreaks 4Health News:HealthTek Software Solutions Licenses First DataBank's OrderView Med Knowledge Base(TM) to Streamline Medication Selection, Management and Reconciliation 2Health News:HealthTek Software Solutions Licenses First DataBank's OrderView Med Knowledge Base(TM) to Streamline Medication Selection, Management and Reconciliation 3Health News:HealthTek Software Solutions Licenses First DataBank's OrderView Med Knowledge Base(TM) to Streamline Medication Selection, Management and Reconciliation 4Health News:CACI Awarded $64 Million Contract to Provide Information Assurance Support for Military Health System 2Health News:CACI Awarded $64 Million Contract to Provide Information Assurance Support for Military Health System 3Health News:CACI Awarded $64 Million Contract to Provide Information Assurance Support for Military Health System 4Health News:ACS Launches Product to Help Employers Navigate Health Choices For Employees Entering Retirement Years 2Health News:Pediatricians' Group Issues New Autism Guidelines 2Health News:Pediatricians' Group Issues New Autism Guidelines 3Health News:ReliefInsite Launches First Patient Health Record on Facebook(R) Platform 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: