Navigation Links
Alimera Announces Positive Results From the Two Phase 3 FAME(TM) Trials of Iluvien(R) in Patients With Diabetic Macular Edema
Date:12/23/2009

ATLANTA, Dec. 23 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported top-line results from the month 24 readout of the FAME Study.

The FAME Study consists of two Phase 3 pivotal clinical trials (Trial A and Trial B) for the use of Iluvien in the treatment of diabetic macular edema (DME). The primary efficacy endpoint for the FAME Study is the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups.

The month 24 analysis using the Full Analysis Set in Trial A demonstrated statistical significance with 26.8% (p value 0.029) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 26.0% (p value of 0.034) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline. In Trial B, the month 24 data demonstrated statistical significance with 30.6% (p value of 0.030) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 31.2% (p value of 0.027) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline.

The Full Analysis Set includes all 956 patients randomized into the FAME Study, with data imputation employed using last observation carried forward (LOCF) for data missing because of patients who discontinued the trial or are unavailable for follow up. (This data set is commonly referred to as the "intent to treat" population.)

In addition, both the low and high dose Iluvien showed greater numerical efficacy at month 24 than at month 18, a requirement for submission with 24 month data in the United States.

Safety was assessed for all patients tre
'/>"/>

SOURCE Alimera Sciences, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Alimera Sciences Announces Presentation of Data From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study at ARVO 2009 Annual Meeting
2. Alimera Sciences Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout
3. Alimera Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study
4. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
5. DSMB Again Supports Continuation of Alimera Sciences Phase 3 Clinical Trial of Iluvien(TM) for the Treatment of DME
6. Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
7. China Medicine Announces Changes to Management Team
8. PDI Announces New Pharmaceutical Services Business Win With a Top 5 Pharmaceutical Company
9. Jennerex Announces Presentations at Upcoming Conferences
10. Macomb County Announces Final 2009 H1N1 Clinic
11. Access MediQuip Announces Release of Partners in Focus Provider Portal
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... England and PITTSBURGH , ... ) today announced that it received regulatory clearance from ... (EUMR) for its proposed acquisition of Perrigo Company plc ... Executive Chairman Robert J. Coury commented, "Today ... completing our acquisition of Perrigo and serves as further ...
(Date:7/29/2015)... NEW YORK and ...  CMC Biologics, a global leader in clinical ... Development Corporation (River Vision), a private company focused ... into an agreement for the process transfer and ... monoclonal antibody targeting insulin-like growth factor 1 that ...
(Date:7/28/2015)... OAKS, Calif. , July 28, 2015 ... of Directors today declared a $0.79 per share dividend ... be paid on Sept. 8, 2015, to all stockholders ... Aug. 17, 2015.  About Amgen Amgen ... patients suffering from serious illnesses by discovering, developing, manufacturing ...
Breaking Medicine Technology:Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 2Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 3Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 4Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 5Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 6Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 7Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 8Mylan Announces Receipt of Unconditional Clearance from European Commission on Acquisition of Perrigo 9CMC Biologics and River Vision Development Corporation Announce Manufacturing Agreement for RV001, a Monoclonal Antibody to Treat Grave's Orbitopathy 2CMC Biologics and River Vision Development Corporation Announce Manufacturing Agreement for RV001, a Monoclonal Antibody to Treat Grave's Orbitopathy 3Amgen Announces 2015 Third Quarter Dividend 2Amgen Announces 2015 Third Quarter Dividend 3
... Sept. 8 FluoroPharma, Inc. announced today ... Scientific Advisor,will report on two preclinical studies ... (PET) molecular imaging agents for detection,of Alzheimer,s ... World Molecular,Imaging Congress, in Nice, France on ...
... PRINCETON, N.J., Sept. 8 Medarex, Inc.,(Nasdaq: ... milestone payment for an,undisclosed amount from its licensing ... is a result of the submission of an ... clinical development of an antibody,generated by Medarex,s UltiMAb(R) ...
Cached Medicine Technology:FluoroPharma, Inc. to Report Preclinical Data on Alzheimer's Disease and Prostate Cancer PET Imaging Agents 2FluoroPharma, Inc. to Report Preclinical Data on Alzheimer's Disease and Prostate Cancer PET Imaging Agents 3Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing 2Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing 3
(Date:7/29/2015)... ... July 29, 2015 , ... TransFlip is an all ... drag & drop presets for FCPX, these transitions are easy to apply and modify ... to each transition. With over 60 preset styles, kinetic flipping panel animations are just ...
(Date:7/29/2015)... (PRWEB) , ... July 29, 2015 , ... The ... The project, which will by the end will cost the 501(c) organization nearly $1 ... Arizona’s recent anti-ligature requirements. , “We took it down to the studs,” said ...
(Date:7/29/2015)... ... 29, 2015 , ... HealthPostures ( https://healthpostures.com ), a sit ... an ergonomics specialty firm. Purpose of the partnership is to help strengthen and ... improve worker mobility, functionality and fitness levels. , Executives at HealthPostures and ...
(Date:7/29/2015)... , ... July 29, 2015 , ... ... the first dermatologist in Sarasota to be chosen by the manufacturer to offer ... offers the first injectable, non-invasive way to treat and eliminate double chin fat,” ...
(Date:7/29/2015)... ... July 29, 2015 , ... ITW Dynatec, along with Zip-Pak ... Powers is responsible for driving growth and innovation across ITW Dynatec’s worldwide customer ... as an effective leader within the ITW community speaks for itself. We are ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios Releases FCPX Transition TransFlip for FCPX 2Health News:The New Foundation AZ Renovates Residential Dorms for Youth in Crisis 2Health News:The New Foundation AZ Renovates Residential Dorms for Youth in Crisis 3Health News:HealthPostures and 247Ergo Partnership Strengthens America's Wellness 2Health News:HealthPostures and 247Ergo Partnership Strengthens America's Wellness 3Health News:SkinSmart Dermatology is First in Sarasota to Offer Kybella Treatments to Reduce Double Chin Fat 2Health News:SkinSmart Dermatology is First in Sarasota to Offer Kybella Treatments to Reduce Double Chin Fat 3Health News:Gina Powers Named Vice President & General Manager of ITW Dynatec 2Health News:Gina Powers Named Vice President & General Manager of ITW Dynatec 3
... IQ tests compared to better-off peers , , FRIDAY, Dec. ... neighborhoods fall behind the equivalent of one year or ... , "[The study] does speak to the power ... and special education in the division of developmental and ...
... overdose, death from fentanyl-laden patches , , , FRIDAY, Dec. ... years, U.S. health officials are warning of reports of deaths ... patches that are prescribed to treat chronic pain. , The ... They are primarily used by cancer patients who are tolerant ...
... Products in our Molluscum Line,in the First Quarter ... ReBuilder,Medical Technologies, Inc. (Pink Sheets: RBRM), developers ... peripheral neuropathy, Molluscum,Contagiosum, and MRSA, announces 4th quarter ... http://www.newscom.com/cgi-bin/prnh/20061128/REBUILDERLOGO ), "We are projecting ...
... Corporation,(Nasdaq: MASI ), the inventor of Pulse CO-Oximetry ... that it is scheduled to,present at the 26th Annual ... Francisco, CA on Monday, January 7, 2008 at 8:30 ... P. de Raad, Executive Vice,President and CFO, will be ...
... from 3 to 4 per day after service was added ... -- Simply adding a salad bar to the school lunch ... vegetables, U.S. researchers say. , The University of California, Los ... at three L.A. area schools. The children were interviewed before ...
... 2007, CONCORD, Ontario, Dec. 21 On ... ,the Company,), a,leading multi- industry computer hardware, software ... an order for 100TB SAN dedicated,to pioneering cancer-related ... hospitals. The EqualLogic iSCSI SAN order is in ...
Cached Medicine News:Health News:Kids in Poor Neighborhoods Fall Behind in School 2Health News:FDA Renews Warnings on Pain-Relief Patch 2Health News:FDA Renews Warnings on Pain-Relief Patch 3Health News:FDA Renews Warnings on Pain-Relief Patch 4Health News:ReBuilder Medical Technologies, Inc. 4th Quarter Sales Increase 100% Exceeding Projections 2Health News:Masimo to Present at 26th Annual JPMorgan Healthcare Conference 2Health News:School Salad Bar Boosts Kids' Fruit, Veggie Intake 2Health News:On The Go Ships 100TB Hardware Order for Ground-Breaking Cancer Imaging and Therapy Projects 2Health News:On The Go Ships 100TB Hardware Order for Ground-Breaking Cancer Imaging and Therapy Projects 3
... marvel of engineering and innovative design, ... unparalleled quality and masterful workmanship. At Burton, ... the ophthalmic industry a truly innovative concept, ... product design to quality construction and stringent ...
... Set one of two memory positions to ... touch auto return button, Durable upholstery, Elegant ... Solid-State push button control panel with three ... Electro-Magnetic counter-balanced slit lamp arm for easy, ...
Our Ophthalmic Diagnostic Sets offer everything an eye care specialist needs. Complete your set with your choice of ophthalmoscope, retinoscope, handle, and case....
3.5v Ophthalmic Diagnostic Set with AutoStep Coaxial Ophthalmoscope, Spot Retinoscope, Rechargeable Handle, and Soft Case. High-quality eyecare from the preferred name in diagnostic instruments....
Medicine Products: