Navigation Links
EYLEA™ (aflibercept injection) Submitted in Japan for Marketing Authorization for the Treatment of Wet Age-Related Macular Degeneration
Date:6/28/2011

ubmitted for marketing approval for the treatment of wet AMD in the U.S. in February 2011 by Regeneron and in Europe in June 2011 by Bayer HealthCare.

Bayer HealthCare will market EYLEA™ outside the United States, where the companies will share equally the profits from any future sales of EYLEA.  Regeneron maintains exclusive rights to EYLEA in the United States.

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 EYLEA™ in the treatment of the neovascular form of age-related macular degeneration (wet AMD).  The VIEW 1 study, which randomized 1,217 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 1,240 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, EYLEA 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 mg monthly, or 2 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.  As-needed (PRN) dosing with both agents, with a dose administered at least every three months (but not more often than monthly), is being evaluated during the second year of each study.

About EYLEA

EYLEA is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).  EYLEA is a specific and highly potent blocker of these growth fac
'/>"/>

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

Page: 1 2 3 4 5 6

Related biology technology :

1. Shire Presents Data at ACMG for Fabry and Gaucher Patients Who Switched to Replagal® (agalsidase alfa) and VPRIV® (velaglucerase alfa for injection)
2. Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
3. Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
4. Infusion Nurses Society References Totect(R) (Dexrazoxane For Injection) as the Only Antidote for the Treatment of Anthracycline Extravasation
5. Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System
6. FDA Approves Astellas Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
7. Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval
8. Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
9. Reverse NanoJapan: Rice to host 25-30 Japanese students
10. Cellectis bioresearch Appoints Wako as Exclusive Distributor of its Genome Customization Solutions in Japan
11. Epichem and AR Brown Sign Exclusive Distribution Agreement for Japan, Taiwan, China and South Korea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... BCC Research ( http://www.bccresearch.com ) reveals in ... (PCR) TECHNOLOGY: GLOBAL MARKETS , the global market for ... billion in 2013. This is estimated to grow to ... growth rate (CAGR) of 28.6%. , New digital PCR ... possibilities within the broader PCR field. The opportunities presented ...
(Date:7/11/2014)... SEATTLE , July 11, 2014  Researchers ... navigate three-dimensional images. The new technology, called Virtual ... of small structures like neurons and synapses using ... Finger,s unique technology makes 3D imaging studies orders ... resources at an unprecedented level across many areas ...
(Date:7/10/2014)... Toronto, Canada (PRWEB) July 10, 2014 ... often present in very low abundance and are ... quite challenging and time-consuming. , Join presenters Dr. ... Laboratories, and Dr. John Anders, Head of Quality ... mass spectrometer-based approach that can speed detection and ...
(Date:7/10/2014)... (PRWEB) July 10, 2014 Terascala, the ... announced that Alan Swahn, a former vice president of ... team as vice president of marketing. Terascala’s software when ... and NetApp create the highest performance and most reliable ... appointed to guide Terascala’s channel expansion and broaden its ...
Breaking Biology Technology:Global Market for Digital Polymerase Chain Reaction Technology to Reach $490 Billion by 2018; Equipment Sector Accounts for the Fastest Growing Segment With 33% CAGR 2Global Market for Digital Polymerase Chain Reaction Technology to Reach $490 Billion by 2018; Equipment Sector Accounts for the Fastest Growing Segment With 33% CAGR 3Virtual Finger Enables Scientists To Navigate And Analyze 3D Images Of Complex Biological Structures 2Virtual Finger Enables Scientists To Navigate And Analyze 3D Images Of Complex Biological Structures 3Novel Ms Techniques Speed Detection of Biopharmaceutical Product and Process Impurities, New Webinar Hosted by Xtalks 2Terascala Expands Executive Team 2Terascala Expands Executive Team 3
... , Aiguo Zhang, Allora Aguilera, Chate Luu, Ivan Huang,Diana Davis, Chloe Etienne, Yong Song, Reni Thomas,Kris ... Bio-Rad Laboratories, Life Science Group, 2000 Alfred Nobel Drive, , Hercules, ... Presented by the Author at The American Society for Cell Biology , December ... , , , ...
... Data submitted by Dr. Ivan Kaiser, University of Wyoming,Laramie, WY USA , ... , Dr. Ivan Kaisers research involves ... snake venom, such as post-synaptic neurotoxins and hemorrhagic , ... purification, in which students study the principles of protein ...
... , , , AquaPure RNA Isolation Kit ... g RNA, , Method , ... 1.Add 50100 mg (0.050.1 g) frozen ground tissue or fresh tissue to a , ... Grind , frozen tissue finely in liquid nitrogen with a porcelain ...
Cached Biology Technology:Total RNA Isolation From 50100 mg Plant Tissue 2
(Date:7/10/2014)...  Unisys Corporation,s (NYSE: UIS ) subsidiary in ... announced that it has been selected by the Dutch Custodial ... Basic Provision Biometrics solution for penitentiaries across The ... with a solution based on its open standards-based LEIDA ... contract is up to seven years, with the new system ...
(Date:7/10/2014)... -- NXT-ID, Inc., (OTCQB: NXTD) a biometric authentication company focused on the ... was interviewed on July 1 st on the ... . Mr. Pereira discusses the company,s next generation smart wallet ... the Wocket™ aims to replace a traditional wallet with a ... tells Gino he has never heard of the Wocket ...
(Date:7/10/2014)... DUBLIN , July 3, 2014 ... the addition of the "Global Gesture Recognition ... Market - Forecasts to 2020" report to ... Global Gesture Recognition & Touch-Less Sensing ... been around for a while, but the companies ...
Breaking Biology News(10 mins):Unisys Delivers New Basic Provision Biometrics Solution to Dutch Custodial Institutions Service 2Unisys Delivers New Basic Provision Biometrics Solution to Dutch Custodial Institutions Service 3Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 2Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 3Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 4Global Gesture Recognition & Touch-Less Sensing (2D, 3D, Ultrasonic, IR, Capacitive) Market - Forecasts to 2020 2
... and interaction of microbes is essential for promoting human ... Ecological Society of America,s (ESA) 96th Annual Meeting from ... microbes of the human body and other research on ... 2011 meeting in Austin, Texas. Bellybutton microbiomes ...
... RICHLAND, Wash. Today, farming often involves transporting crops ... enjoy Midwest corn, Northwest cherries and other produce when ... just the fossil fuel needed to move food that ... in the journal Biogeosciences provides a detailed account of ...
... When we make plans that will change a natural ... planting a new forest surveyors dutifully assess the environmental ... what,s environmentally good for one area may be an environmental ... cautions. When displaced by these projects, indigenous species ...
Cached Biology News:Carbon hitches a ride from field to market 2Carbon hitches a ride from field to market 3Carbon hitches a ride from field to market 4Raptor usurpers in neighboring habitats reshape the conventional wisdom 2Raptor usurpers in neighboring habitats reshape the conventional wisdom 3
... (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrasodium bromide), 50mg/vial. MTT is a ... living cells to yield a dark blue ... and even freshly dead cells do not ... is a component of Chemicons MTT assay ...
Piperazine-N',N'-bis(2-ethanesulfonic acid), monosodium salt...
Mouse monoclonal [CAT-2] to Chloramphenicol Acetyltransferase...
... Immunogen: Immunogen corresponds to amino acids ... SKAP55.,PA1-525 has been successfully used in Western ... Western blot, this antibody detects an ~ ... antibody has also been used in immunoprecipitation ...
Biology Products: