Navigation Links
Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
Date:2/22/2011

n research to measure visual acuity.  Maintenance of vision was defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS eye chart.

The following table summarizes the VIEW 1 and VIEW 2 results for the primary and the first secondary endpoint pre-specified for testing:Ranibizumab
0.5mg monthlyVEGF Trap-Eye
0.5mg monthlyVEGF Trap-Eye
2mg monthlyVEGF Trap-Eye
2mg every 2
monthsMaintenance of vision* (% patients losing <15 letters) at week 52 versus baseline VIEW 1

94.4%

95.9%**

95.1%**

95.1%**VIEW 2

94.4%

96.3%**

95.6%**

95.6%**Mean improvement in vision* (letters) at 52 weeks versus baseline (p-value versus ranibizumab 0.5mg monthly)***VIEW 1

8.1

6.9 (NS)

10.9 (p<0.01)

7.9 (NS)VIEW 2

9.4

9.7 (NS)

 7.6 (NS)

8.9 (NS)*Visual acuity was measured as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart**Statistically non-inferior based on a non-inferiority margin of 10%, using confidence interval approach (95.1% and 95% for VIEW 1 and VIEW 2, respectively)*** Test for superiorityNS=not statistically significantIn the VIEW 1 and VIEW 2 trials, a generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The incidence of ocular treatment emergent adverse events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease, and/or the aging process.  The most frequent ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters.  The most frequent serious non-ocular adverse events were typical of those reported in this elderly population who receive intravitreal treatment for wet AMD; the most frequently reported e
'/>"/>

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

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
5. Regeneron Reports Third Quarter 2009 Financial and Operating Results
6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration
7. Regeneron Announces Presentation at the Deutsche Bank 2009 Biotech Boston Confab
8. BioMed Realty Trust Signs New Lease With Regeneron Pharmaceuticals for 131,000 Square Feet at Landmark
9. Regeneron Announces Presentation at the Morgan Stanley Global Healthcare Conference
10. Regeneron Announces Presentation at the UBS Global Life Sciences Conference
11. Regeneron Announces Panel Discussion at Citis 5th Annual Biotech Day
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/4/2015)... March 4, 2015  Nevro Corp. (NYSE: ... and commercialized an innovative, evidence-based neuromodulation platform for the ... release financial results for the fourth quarter  and full ... 18, 2015. Company management will host a conference call ... Time) on Wednesday, March 18, 2015. ...
(Date:3/4/2015)... -- Mail-service and specialty pharmacies will save ... plans $11.8 billion over the next decade, according ... Association (PCMA). "Home delivery of traditional ... ways to reduce health costs," said PCMA President ... resist efforts to restrict these cost-saving tools." ...
(Date:3/4/2015)... , March 4, 2015 From ... attending the 2015 Distribution Management Conference and Expo ... conference is HDMA,s largest supply chain education event, ... third parties who keep the pharmaceutical distribution industry ... on regulatory and legislative issues important to healthcare ...
Breaking Medicine Technology:PCMA: Report Shows High-Tech Specialty and Mail-Service Pharmacies Will Reduce Costs for Illinois Employers, Consumers and Public Programs by $11.8 Billion 2
... Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced,that the ... safety of,Bronchitol in subjects with bronchiectasis has concluded ... following 12 months of treatment., A total ... Bronchitol twice,per day and 99 subjects completed the ...
... 19 Particle Sciences Inc. has,expanded its ... capabilities with the installation of a compounding,extrusion ... the pilot line,comprising a Haake twin-screw compounding ... production of high-quality drug loaded polymeric,devices. This ...
Cached Medicine Technology:12 Month Phase 3 Trial Finds Bronchitol Safe in Bronchiectasis 212 Month Phase 3 Trial Finds Bronchitol Safe in Bronchiectasis 3Particle Sciences Expands Its Combination Product Capabilities 2
(Date:3/4/2015)... When people talk about venues being the place to be ... the Houston Rodeo will be a name that ... livestock show and rodeo, one popular band will perform for ... at the event. The 2015 show will feature one of ... get the festival its largest attendance ever. , Houston Rodeo ...
(Date:3/4/2015)... WV (PRWEB) March 04, 2015 TROY ... (TSPE) software, which provides the ultimate level of security ... at the Hilton Houston Plaza Medical Center located at ... , Beginning at 7 AM, TROY Healthcare Solutions ... TROY Healthcare Solutions will offer brief presentations each hour ...
(Date:3/4/2015)... March 04, 2015 The ability ... in density assessment and help improve breast cancer ... abstracts accepted for presentation at the European Congress ... Ten abstracts - eight posters and 2 session ... automated breast density and quantitative breast imaging software ...
(Date:3/4/2015)... Blake’s All Natural Foods , ... attend this year’s Natural Products Expo West in Anaheim, ... this new line, Blake’s, who has the top four ... its commitment to creating high-quality dishes that are easily ... the natural channel, Blake’s understands what educated consumers are ...
(Date:3/4/2015)... (PRWEB) March 04, 2015 Vancouver ... recently received two awards in the prestigious Vancouver ... on February 27, 2015. The company secured third ... place in the “Best Registered Massage Therapist” category. ... community newspapers in Canada, The Vancouver Courier is ...
Breaking Medicine News(10 mins):Health News:Cheap Houston Rodeo Tickets: Ticket Down Slashes Houston Rodeo Tickets for John Legend, Pitbull, Alan Jackson, Tim McGraw, Zac Brown Band, Fall Out Boy & Miranda Lambert 2Health News:Cheap Houston Rodeo Tickets: Ticket Down Slashes Houston Rodeo Tickets for John Legend, Pitbull, Alan Jackson, Tim McGraw, Zac Brown Band, Fall Out Boy & Miranda Lambert 3Health News:TROY Healthcare to Offer Prescription Solutions that can save a Hospital $100,000 2Health News:TROY Healthcare to Offer Prescription Solutions that can save a Hospital $100,000 3Health News:Research Finds Use of Volpara Solutions’ Quantitative Breast Imaging Tools Help Reduce Subjectivity in Density Assessment and Improve Breast Cancer Risk Prediction 2Health News:Research Finds Use of Volpara Solutions’ Quantitative Breast Imaging Tools Help Reduce Subjectivity in Density Assessment and Improve Breast Cancer Risk Prediction 3Health News:Research Finds Use of Volpara Solutions’ Quantitative Breast Imaging Tools Help Reduce Subjectivity in Density Assessment and Improve Breast Cancer Risk Prediction 4Health News:Research Finds Use of Volpara Solutions’ Quantitative Breast Imaging Tools Help Reduce Subjectivity in Density Assessment and Improve Breast Cancer Risk Prediction 5Health News:Fastest Growing Frozen Brand in Natural Channel Showcases New Line at Expo West 2015 2Health News:Fastest Growing Frozen Brand in Natural Channel Showcases New Line at Expo West 2015 3Health News:Backs in Action Receives Two Awards in The Vancouver Courier Readers’ Choice Awards 2015 2
... Institute for Tuberculosis and HIV (K-RITH) has awarded a ... South African scientists and students to help build new ... These are the first Collaborative Grants awarded by K-RITH, ... the University of KwaZulu-Natal (UKZN) and the Howard Hughes ...
... nuclear incident, researchers at Thomas Jefferson University ... an award to find novel drugs to treat people ... of a nuclear terrorist attack or a nuclear accident. ... given to six institutions under the National Institute ...
... 2011 The Translational Genomics Research Institute (TGen) has ... cancer tumors by modifying the actions of proteins. ... mission: To move laboratory discoveries more rapidly into therapeutics ... life. The drug, ONCO-101, is being licensed to ...
... May 4 (HealthDay News) -- Adults often find it hard ... about their wishes and hopes revealed some interesting trends, researchers ... 18, who completed a health screening questionnaire that included the ... be?" The researchers found that 85 percent of participants ...
... and the Management Sciences (INFORMS) will host its first ... 2011 takes place at the Hilton Bonaventure Hotel in ... range from improving the scheduling of patients at clinics ... for beaming radiation at cancer cells. , The conference ...
... News) -- Being sociable can help keep your brain healthy ... University Medical Center found that elderly people with the highest ... friends, going to parties or attending church -- showed much ... least socially active. The study included 1,138 ...
Cached Medicine News:Health News:K-RITH awards grants to foster teamwork among South African TB/HIV scientists 2Health News:Thomas Jefferson University and hospitals tasked to find new radiation drugs 2Health News:TGen licenses first drug for patient use in clinical care 2Health News:Simple Question Sheds Light on Teens' Hopes, Dreams 2Health News:Socializing May Keep Elderly Minds Sharp 2
... is intended for the quantitative determination of Erythropoietin ... for in vitro diagnostic use, as an aid ... the advent of the administration of recombinant erythropoietin ... cell mass, an erythropoietin assay may be used ...
Fully automated immunochemiluminometric assay for the rapid intraoperative,measurement of Intact PTH 1-84 using human serum or EDTA plasma....
Microwell EIA for the detection of EPO (Erythropoietin)...
Microwell IRMA for the detection of Intact PTH...
Medicine Products: