PRNewswire
ATLANTA, March 24 /PRNewswire/ -- After completing its review of safety
and efficacy data currently available, an independent Data Safety Monitoring
Board (DSMB) has once again recommended that the two pivotal Phase III
clinical trials, known collectively as the FAME(TM) (Fluocinolone Acetonide in
Diabetic Macular Edema) Study can continue under the current protocol, without
change. The trial is studying the use of Medidur FA for the treatment of
diabetic macular edema (DME).
FAME is two, duplicate, double-masked, randomized, multi-center studies
that are following 956 patients in the U.S., Canada, Europe and India for 36
months in support of a planned global registration filing, with safety and
efficacy assessed after two years of follow-up. Enrollment for the FAME study
was completed in October 2007.
"Alimera is pleased with the response from the DSMB that they have once
again recommended that our investigative efforts around this treatment
continue without change to the current protocol," said Alimera CEO Dan Myers.
As of this latest DSMB review, we continue to be on track for regulatory
submissions in early 2010."
Earlier this month, Alimera announced that it would be assuming a majority
stake in the development of Medidur FA. Alimera is also working with Emory
University on an exploratory treatment using the Medidur delivery system with
an NADPH oxidase inhibitor for the treatment of dry age-related macular
degeneration (AMD).
Medidur, a tiny, injectable insert, is being studied as a way to deliver
fluocinolone acetonide, a corticosteroid, to the retina for up to three years
as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge
injector system, an eye care professional injects the Medidur insert into the
vitreous through a minimally invasive procedure in an outpatient setting.
Currently, 7.5 percent of the U.S. population has diabetes. Over time,
almost all diabetics will develop some form of diabetic retinopathy, of which
diabetic macular edema is the primary cause of vision loss. In the United
States, as many as 200,000 people are diagnosed with DME each year and an
estimated 1,000,000 people suffer from DME. Currently, there are no FDA
approved drug treatments for DME.
A DSMB provides an independent evaluation of all trial data to identify
potential safety issues that might warrant modification or early termination
of ongoing studies. The FAME DSMB, a group comprised of four ophthalmologists
and a biostatistician, met to review the Medidur FA Phase III clinical trial
data. The DSMB's charter stipulates that a formal review occur every six
months in addition to their ongoing review of the trial.
About Alimera Sciences Inc.
Alimera Sciences Inc. is singularly focused on the development and
commercialization of prescription ophthalmology pharmaceuticals. Founded by an
executive team with extensive development and revenue growth expertise,
Alimera Sciences' products are focused on improving the delivery of
therapeutic agents to enhance patients' lives and strengthen physicians'
ability to manage ocular conditions.
Alimera completed enrollment in October 2007 of its 956-patient Phase III
clinical trial of fluocinolone acetonide in the Medidur(TM) drug delivery
system for the treatment of diabetic macular edema. Alimera has 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 for ophthalmic diseases. The agreement gives
Alimera the exclusive option to license compounds which are NADPH
(nicotinamide adenine dinucleotide phosphate reduced form) oxidase inhibitors
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 retains the right to use the Medidur
delivery system for two of these compounds.