Navigation Links
Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration
Date:11/18/2011

 Both the EYLEA™ (aflibercept) Injection 2Q8 and 2Q4 dosing groups were shown to have efficacy that was clinically equivalent to the ranibizumab 0.5Q4 group for the primary endpoint.

Select results of the VIEW 1 and VIEW 2 studies as described in the full Prescribing Information for the EYLEA 2 mg every four weeks and EYLEA 2 mg every eight weeks dosing groups as compared to ranibizumab dosed monthly group are shown below.

Efficacy Outcomes at Week 52 (Full Analysis Set with LOCF) in VIEW 1 and VIEW 2 Studies VIEW 1VIEW 2 

EYLEA

2 mg Q8 weeks(a)

EYLEA

2 mg Q4 weeks

ranibizu-mab

0.5 mg Q4 weeks

EYLEA

2 mg Q8 weeks(a)

EYLEA

2 mg Q4 weeks

ranibizu-mab

0.5 mg Q4 weeksFull Analysis Set

N=301

N=304

N=304

N=306

N=309

N=291Efficacy Outcomes 

 Proportion of patients who maintained visual acuity (%)

(<15 letters of BCVA loss)

94%

95%

94%

95%

95%

95%Difference(b) (%)

(95.1% CI)

0.6

 (-3.2, 4.4)

1.3

 (-2.4, 5.0)

 

0.6

 (-2.9, 4.0)

-0.3

 (-4.0, 3.3)

 Mean change in BCVA as measured by ETDRS letter score from Baseline

7.9

10.9

8.1

8.9

7.6

9.4Difference(b) in LS mean

(95.1% CI)

0.3

 (-2.0, 2.5)

3.2

(0.9, 5.4)

 

-0.9

 (-3.1, 1.3)

-2.0

 (-4.1, 0.2)

 BCVA = Best Corrected Visual Acuity; CI = Confidence Interval; ETDRS = Early Treatment Diabetic Retinopathy Study; LOCF = Last Observation Carried Forward (baseline values are not carried forward); 95.1% confidence intervals were presented to adjust for safety assessment conducted during th
'/>"/>

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

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Sanofi and Regeneron Report Positive Preliminary Phase 2 Program Results for Anti-PCSK9 Antibody in Hypercholesterolemia
2. Regeneron Pharmaceuticals Announces Pricing of Offering of Convertible Senior Notes due October 1, 2016
3. Regeneron Ranked by Science Magazine as the #2 Employer in the Global Biopharmaceutical Industry
4. Regeneron Announces Clinical Presentations at ASRS 2011 Annual Meeting
5. Regeneron Reports Second Quarter 2011 Financial and Operating Results
6. Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis
7. Trading in Regeneron Common Stock Halted
8. Regeneron Reports First Quarter 2011 Financial and Operating Results
9. Regeneron Announces Presentation at the Bank of America Merrill Lynch 2011 Health Care Conference
10. Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
11. Regeneron and Bayer Announce Start of Phase 3 Clinical Program in Diabetic Macular Edema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2014)... , July 22, 2014  According to the American ... children spend on digital devices. An AOA survey reports ... 10 and 17 estimate they use an electronic device ... separate AOA survey of parents revealed that only 40 ... device for that same amount of time. Eye doctors ...
(Date:7/22/2014)... , July 22, 2014  Vernalis plc (LSE: VER) and ... proof-of-concept (POC) for CCP-08, the third programme to ... cold collaboration. Under this collaboration, POC requires the ... human pilot comparative study against an immediate release ... Vernalis will make a milestone payment to Tris. ...
(Date:7/22/2014)... PORT WASHINGTON, New York , ... Neue Partnerschaft für umfassenden ... gefährlichen Medikamenteneinwirkungen in Österreich    ... führender Anbieter von geschlossenen Transfersystemen (Closed System ... Medikus , einen Vertriebshändler und ...
Breaking Medicine Technology:Survey Reveals Parents Drastically Underestimate the Time Kids Spend on Electronic Devices 2Survey Reveals Parents Drastically Underestimate the Time Kids Spend on Electronic Devices 3Survey Reveals Parents Drastically Underestimate the Time Kids Spend on Electronic Devices 4Third Product in Vernalis' Cough Cold Pipeline (CCP-08) Achieves Proof-of-Concept 2Third Product in Vernalis' Cough Cold Pipeline (CCP-08) Achieves Proof-of-Concept 3Equashield ernennt Medikus zu seinem exklusiven österreichischen Vertriebspartner für seine geschlossenen Arzneimitteltransfersysteme 2
... Jan. 6, 2011 Lexicon Pharmaceuticals, Inc. ... on discovering breakthrough treatments for human disease, announced data ... of a solid oral dose formulation for LX4211, a ... and SGLT2). Results from the study demonstrated ...
... CHAPEL HILL, N.C., Jan. 5, 2011 The ... pipeline is pushing strategy and development executives to ... opportunity lies in combination therapies with branded products ... dose combination (FDC) products can extend a therapeutic ...
Cached Medicine Technology:Lexicon Announces Positive Results from New Clinical Study of LX4211 in Type 2 Diabetes Patients 2Lexicon Announces Positive Results from New Clinical Study of LX4211 in Type 2 Diabetes Patients 3Lexicon Announces Positive Results from New Clinical Study of LX4211 in Type 2 Diabetes Patients 4Report Highlights Successful Strategies for Bringing FDC Products to Market 2
(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: