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:12/24/2014)... 24, 2014  United Therapeutics Corporation (NASDAQ: ... (NYSE: MDT ) has submitted a ... Drug Administration (FDA) for the use of Medtronic,s ... (including a newly developed catheter) for use with ... intravenously to patients with pulmonary arterial hypertension.   ...
(Date:12/24/2014)... NEW YORK , Dec. 24, 2014 ... advancing patient care in critical areas, announced the closing ... common stock, and warrants to purchase up to an ... price of $4.00 per share and $.01 per warrant.  ... $5.00, are exercisable immediately, and expire 5 years from ...
(Date:12/24/2014)... 2014  Vermillion, Inc. (Nasdaq:   VRML), a ... today that the Company closed its previously announced ... Jack W. Schuler , Birchview Fund LLC ... million, before offering expenses.  The proceeds will be ... Under the terms of the private ...
(Date:12/24/2014)... 2014   BioLife Solutions , Inc. (NASDAQ: ... of proprietary clinical grade hypothermic storage and ... shipping products for cells and tissues  ("BioLife" or ... 2015 Annual Meeting of Stockholders on May 4, 2015 ... for the Annual Meeting represents a change of more ...
Breaking Biology Technology:United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 2PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 3Vermillion Announces Closing of Equity Financing 2Vermillion Announces Closing of Equity Financing 3BioLife Solutions Sets Date for Annual Meeting of Stockholders 2
... N.C., Aug. 26 SciQuest, Inc ., ... and supplier enablement solutions, was ... of the fastest-growing, private companies in America. SciQuest ... 2007. (Logo: http://photos.prnewswire.com/prnh/20100624/DA25925LOGO ) ...
... Year Results Interviews With CEO and CFO -- LONDON, August 26, 2010 ... ... ... // Results are keyed by longUrl, so we need to grab the first one. for (var r ...
... A new study from researchers in Canada and Sweden has ... eye tissue and improve vision in humans. The results, from ... in the August 25th, 2010 issue of Science Translational ... the first to show that an artificially fabricated cornea can ...
Cached Biology Technology:SciQuest Makes the Inc. 500|5000 List of Fastest-Growing Companies for Fourth Consecutive Year 2Hikma - Half Year Results Interviews With CEO and CFO 2Hikma - Half Year Results Interviews With CEO and CFO 3Hikma - Half Year Results Interviews With CEO and CFO 4Hikma - Half Year Results Interviews With CEO and CFO 5Seeing the world with new eyes: Biosynthetic corneas restore vision in humans 2
(Date:12/24/2014)... YORK , Dec. 23, 2014  Since its launch ... helped thousands of people to eliminate the pain of ... the antiquated system with their own biometrics fused to ... remember usernames and passwords, Hoyos Labs , the ... announced today that it is offering the app for ...
(Date:12/22/2014)... Dec. 22, 2014  NXT-ID, Inc. (NASDAQ: ... biometric authentication company focused on the growing mobile commerce ... security consultant, Apollo Robbins for the 2015 ... Apollo Robbins will be ... , 2015, demonstrating some of his famous theft techniques ...
(Date:12/22/2014)... Dec. 22, 2014 Research and Markets ... the addition of the "The Global ... their offering. ... an overview of the global digital media ... control and monitor piracy by securely and ...
Breaking Biology News(10 mins):1U Offers Best Solution to the Username / Password Dilemma: For FREE! 21U Offers Best Solution to the Username / Password Dilemma: For FREE! 3NXT-ID Hires Master Pickpocket and Security Consultant Apollo Robbins for Wocket Smart Wallet CES 2015 Debut 2NXT-ID Hires Master Pickpocket and Security Consultant Apollo Robbins for Wocket Smart Wallet CES 2015 Debut 3NXT-ID Hires Master Pickpocket and Security Consultant Apollo Robbins for Wocket Smart Wallet CES 2015 Debut 4The Global Watermarking and Fingerprinting Markets 2
... (March 31, 2011) Researchers at The Johns Hopkins ... are more likely to become contaminated with unacceptably high ... with traditional manually operated faucets. The study will ... the Society for Healthcare Epidemiology of America (SHEA). ...
... Missouri Botanical Garden (MBG) has played a significant role in ... Ecuador and Peru, Y. quadrata and Y. ... samples that are gifted to the Missouri Botanical Garden for ... year, new genera are extremely uncommon, and being coupled with ...
... report presents a 20-year road map for increasing U.S. resilience ... highly populated area. The report was mostly written prior ... of experts who authored it noted that the Japanese experience ... in a country acknowledged as a leader in implementing earthquake-resilience ...
Cached Biology News:Electronic faucets unsafe for use in high-risk patient hospital settings 2Missouri Botanical Garden makes rare discovery of plant genus 2US earthquake resilience needs strengthening, says new report 2US earthquake resilience needs strengthening, says new report 3
... The Lumat tube luminometer provides the sensitivity ... purpose luminometer. Advanced digital photon counting with ... match of spectral demands. Equipped with up ... ideally suited for reporter gene assays as ...
... allows for rapid, convenient, and efficient native ... process utilizes a spin column to make ... concentration of proteins which were electro-eluted in ... ion exchangers, offering high binding capacity fo ...
MAb to HLA, Class II-DR+DP Dry Ice: No Preservative: NaN3 Availability When Not in Inventory: 14-21 Business Days...
Cell Culture Flask, nontreated polystyrene...
Biology Products: