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 intravitreal injection, a procedure commonly employed by retinal specialists.

Currently, nearly 24 million people, or 8 percent of the population, in the U.S. have diabetes. Over time, all diabetics are at risk of developing some form of diabetic retinopathy, an ophthalmic condition of diabetes. In the U.S., diabetic retinopathy causes approximately 12,000 to 24,000 new cases of blindness each year, making diabetes the leading cause of new cases of blindness in adults aged 20 to 74. Based on published data, Alimera estimates that there are as many as 300,000 new cases of DME each year and 1,000,000 people have DME. There are no ophthalmic drug therapies currently approved by the U.S. Food and Drug Administration for the treatment of DME.

About Alimera Sciences, Inc.

Alimera Sciences is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently the company is focused on diseases affecting the back of the eye, or retina. Its most advanced product candidate is Iluvien(TM), which is being developed for the treatment of diabetic macular edema, or DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Under one protocol, enrollment was completed in October 2007 in two Phase 3 pivotal trials for the use of Iluvien in the treatment of DME conducted across the U.S., Canada, Europe and India.

Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management -- specifically the reduction of reactive oxygen species (ROS) -- as a treatment strategy for ophthalmic diseases. Under this agreement, Alimera has acquired options to exclusive, worldwide licenses for two classes of nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors, which Alimera is studying as potential treatments for conditions such as the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy. Alimera has exercised its option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.


'/>"/>
SOURCE Alimera Sciences, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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:7/31/2017)... -- 7D Surgical, developer of ground breaking surgical navigation technologies, ... System to support its strategic sales plan in ... Virginia.  7D Surgical has entered into an exclusive sales representative ... facilities within those markets. ... Spartan Medical Purchases 7D ...
(Date:7/27/2017)... 2017  Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) ... 30, 2017.  The Company reported second quarter net sales ... prior year period, and an increase of 2.1% on ... of contribution from the LDR Holding Corporation acquisition, second ... of 2016, or 0.3% on a constant currency basis. ...
(Date:7/26/2017)... Aesthetics, a leading medical aesthetic clinic in Singapore ... skin conditions from the inside. The natural process of ... skin becomes more transparent due to the thinning of the epidermis. Over ... the sun contributes to aging skin, causing age spots and other ... ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... August 18, 2017 , ... The Golseth Agency, a Texas based insurance management ... spearheading a regional charity campaign organized to provide support to Christina Upchurch and her ... year, Christina and her children returned from out of town to find her husband ...
(Date:8/18/2017)... ... August 18, 2017 , ... Alcovit, a lime-flavored beverage that ... its marketing efforts with its product now available through Jet.com. , After 25 ... The effervescent powdered drink is designed to quickly detox the body thereby avoiding alcohol-induced ...
(Date:8/18/2017)... ... ... “Dangerous Inheritance”: a mystery about saving the family farm. “Dangerous Inheritance” is the ... was raised on a farm. As Diane wrote this story, she used fond ... mantra of ‘neighbors helping neighbors’ have always been a large part of her farming ...
(Date:8/18/2017)... ... August 18, 2017 , ... Rollon Skin ... anti-aging skincare solutions, recently announced the launch of two new skincare products, ... yet effective alternative to expensive plastic surgery or in-patient cosmetic dermatological procedures. , ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... Coatesville Veterans Affairs Medical Center. “Case #10-5411 Veterans Administration” is the creation ... domestic abuse. In June 1990, Carol Mulhem started work at the Coatesville ...
Breaking Medicine News(10 mins):