Navigation Links
Alimera Sciences' Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout
Date:4/8/2009

ATLANTA, April 8 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of two pivotal Phase 3 clinical trials for the use of Iluvien(TM) in the treatment of diabetic macular edema (DME) under the current protocol, without change. The Board completed its final review of the currently available safety and efficacy data prior to the readout in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.

These clinical trials, known collectively as the FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multi-center trials in the U.S., Canada, Europe and India in support of a planned global registration filing. Safety and efficacy will be assessed after 24 months of follow-up, which will occur in October of this year.

"Alimera is pleased that the DSMB recommended the continuation of the FAME Study without change," said Alimera CEO Dan Myers. "We are looking forward to the last patient, last visit for the 24-month readout scheduled in October later this year."

Iluvien is an intravitreal insert being developed for the treatment of DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 36 months for the low dose and up to 24 months for the high dose. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intra
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Alimera Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study
2. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
3. DSMB Again Supports Continuation of Alimera Sciences Phase 3 Clinical Trial of Iluvien(TM) for the Treatment of DME
4. Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
5. YM BIOSCIENCES ANNOUNCES NIMOTUZUMAB PRESENTATIONS TO BE MADE AT THE 100TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH AND EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY
6. Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C
7. Sangamo BioSciences Announces Presentations at Two Upcoming Investor Conferences
8. Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblastic Leukemia
9. Intellect Neurosciences, Inc. Announces Independent Studies on Copper Binding Properties of its Lead Candidate OXIGON(TM)
10. Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound
11. Human Genome Sciences Announces Fourth-Quarter and Full-Year 2008 Financial Results and Key Developments
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 2014 /PRNewswire-iReach/ -- VAPETEK™, Inc. has announced a ... use in portable vaporizers, which contains CBD, or ... cannabis, cannabidiol offers consumers a THC-free product made ... vaporizer technology. Photo - http://photos.prnewswire.com/prnh/20140711/126344 ... different compounds which are currently known, two of ...
(Date:7/11/2014)... 2014 Patient engagement has become a ... are turning to an assortment of marketing activities ... of this evolving approach to patient engagement, marketers ... engage patients throughout their experiences with a disease ... mapping the patient journey and employing a consumer ...
(Date:7/11/2014)... 2014 The consumer marketing playbook and ... sectors to better identify winning tools and techniques. ... with and understand consumers, as new technologies are ... purchasing decisions. According to recent ... area where organizations can observe a deep pool ...
Breaking Medicine Technology:VAPETEK Releases CBD-Infused eLiquid For The Consumer Market 2New Study Uses Six-Step Patient Journey as Framework for Consumer-Focused Marketing Opportunities 2New Technologies Transforming Consumer Marketing Research Playbook 2
... ROCKVILLE, Maryland and SURESNES, France, Dec. 1, ... biotechnology company that develops next generation antibody ... company, announced today that they have entered ... for the development and commercialization of MGA271, ...
... 2011 The U.S. Food and Drug Administration today ... Lipitor (atorvastatin calcium tablets). (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ... approval to make generic atorvastatin calcium tablets in 10 ... The drug will be manufactured by Ohm Laboratories in ...
Cached Medicine Technology:MacroGenics and Servier Enter Development and Commercialization Agreement for Novel Anti-Cancer Drug 2MacroGenics and Servier Enter Development and Commercialization Agreement for Novel Anti-Cancer Drug 3MacroGenics and Servier Enter Development and Commercialization Agreement for Novel Anti-Cancer Drug 4FDA Approves First Generic Version of Cholesterol-Lowering Drug Lipitor 2FDA Approves First Generic Version of Cholesterol-Lowering Drug Lipitor 3
(Date:7/12/2014)... According to the new market research report "Security ... Naval Systems) - Global Forecasts and Analysis to 2014 ... market are estimated to be $6.08 billion in 2014 ... to reach $8.61 billion by 2020. , Browse more ... through 161 pages and in-depth TOC on "Security and ...
(Date:7/12/2014)... 13, 2014 Recently, Fadhits.com, a well-known wedding ... elegant long graduation dresses to its product line. ... its loyal clients. It wants to bring more benefits for ... now offered at discounted prices, up to 72% off. , ... always working hard. Its online shop is a good place ...
(Date:7/12/2014)... Recently, iFitDress.com, one of the world’s leading ... red evening gowns . What’s more, all these hot outfits ... The company’s senior spokesman states, “We are proud to announce ... is an enjoyable shopping experience. In addition to the big ... low prices do not always mean bad quality. All the ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 The ... over the past five years, buoyed by stable demand ... supply management system. “Eggs are a relatively affordable staple ... capita egg consumption generally grows in line with the ... Will McKitterick. Furthermore, demand for new specialty egg products ...
(Date:7/12/2014)... Passenger Information System market is estimated to grow from ... at an expected CAGR of 26.5% for the period ... in North America is well developed and network infrastructure ... the region. The growing ridership figures in public transport ... driving the North American Passenger Information System market at ...
Breaking Medicine News(10 mins):Health News:Security and Surveillance Radar Market Estimated to Reach $8.61 Billion by 2020 – New Report by MarketsandMarkets 2Health News:Security and Surveillance Radar Market Estimated to Reach $8.61 Billion by 2020 – New Report by MarketsandMarkets 3Health News:Security and Surveillance Radar Market Estimated to Reach $8.61 Billion by 2020 – New Report by MarketsandMarkets 4Health News:New Collection of Long Graduation Dresses Revealed by Fadhits.com 2Health News:Discounted Red Evening Gown Announced by iFitDress.com 2Health News:Chicken Egg Production in Canada Industry Market Research Report Now Available from IBISWorld 2Health News:Chicken Egg Production in Canada Industry Market Research Report Now Available from IBISWorld 3Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 4
... deficiencies in healthcare provision in parts of Mecklenburg-West Pomerania. ... Greifswald University and her coauthors in the current edition ... 2010; 107[18]: 328-34). They emphasize that similar trends can ... The demographic transition leads to an increase in the ...
... ... prevention of a wide range of both common and rare diseases are possible before ... ... new Existence! Existence Genetics LLC, the world’s first predictive medicine company, is ...
... ... continues to challenge scientists. There is growing evidence that increases in protease ... team of scientists at the University of Alabama measured a common protease ... with healthy volunteers. Previous studies have shown increases in MMP-9 in CF ...
... ... Citrix and Insight Venture Partners , ... Philadelphia, PA (Vocus) May 20, 2010 -- PHD Virtual Technologies , pioneer and ... investment agreement with Citrix Systems, a leading provider of virtual computing solutions that help companies ...
... rosemary, turmeric, fingerroot inhibited production of carcinogenic compounds , ... certain spices to your burgers before tossing them on ... the flavor of the meat, but they can also ... cooking of beef. , Scientists at Kansas State University ...
... ... NanaWall Systems, Inc. announces the NanaWall SL60 is featured in the ... sponsored by the USGBC for interior designers to showcase the best ... The NanaWall connects the hotel suite to an outdoor lounge ...
Cached Medicine News:Health News:Existence Genetics is Pioneering the Field of Predictive Medicine - Nexus Technologies Critical in Understanding and Preventing Deadly Disease 2Health News:Existence Genetics is Pioneering the Field of Predictive Medicine - Nexus Technologies Critical in Understanding and Preventing Deadly Disease 3Health News:News from Molecular Medicine 2Health News:PHD Virtual Technologies Announces Citrix Investment 2Health News:PHD Virtual Technologies Announces Citrix Investment 3Health News:PHD Virtual Technologies Announces Citrix Investment 4Health News:Some Spices Cut Cancer Risk That Comes With Grilled Burgers 2Health News:NanaWall Featured in Award-winning Green Hotel Suite 2Health News:NanaWall Featured in Award-winning Green Hotel Suite 3
... Donor Screening: The Procleix System ... safety to the nation's blood supply. It ... target capture, and a unique nucleic acid ... HIV-1/HCV Assay can simultaneously detect the presence ...
... Test (Reveal Test) is MedMiras flagship rapid ... human serum or plasma against HIV-1 that ... to HIV infection. The Reveal Test is ... and is comprised of a single-use test ...
The Becton™ Colles Fracture Plate has proven clinical outcomes and has excellent patient acceptance compared to external fixation. It provides a cost effective treatment option through a simple...
X-Hair Trephines...
Medicine Products: