ATLANTA, Oct. 3 /PRNewswire/ -- Alimera Sciences Inc., a dynamic ophthalmic pharmaceutical company, in collaboration with Control Delivery Systems Inc. (CDS), a leader in innovative drug delivery systems for the eye, recently initiated a Phase III clinical trial to study diabetic macular edema (DME) patients treated using Medidur(TM) with fluocinolone acetonide, the companies' pharmacologic treatment for DME.
The masked, randomized, multi-center study will follow 900 patients in the U.S. and Europe for 36 months. Patients will receive the Medidur implant, which is small enough to be injected through a needle during an in-office procedure and is expected to provide sustained delivery of fluocinolone acetonide to the back of the eye for up to three years.
"Advanced therapies require innovative methods of delivery, and Medidur fits that model. The Alimera Sciences team is delighted to reach this critical product development milestone with CDS at such a stage of our company's progression," said Dan Myers, CEO of Alimera Sciences. "We anticipate that Medidur technology will allow eye care professionals to provide their DME patients with an effective and long-lasting therapeutic treatment."
In February 2005, Alimera Sciences and CDS announced a worldwide agreement to co-develop and market Medidur using fluocinolone acetonide to treat DME. Alimera Sciences also has the option to develop three additional products using Medidur.
"We are very pleased to have entered Phase III with this next generation of intraocular drug delivery systems," said Paul Ashton, CEO of CDS. "The first two products for CDS, Vitrasert(R) and Retisert(TM), are the only two sustained release systems approved by the FDA for the back of the eye."
DME is a common complication of diabetic retinopathy and is caused by fluid build-up in the central vision portion of the retina. In 2002, the Centers for Disease Control and Prevention estimated the prevalence of diabetes in the United States to be 18.2 million persons. Research indicates that up to 10 percent of all diabetes patients develop DME during their lifetimes.
The only approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots. While there are no drugs approved by the FDA for DME, there is clinical evidence that corticosteroids reduce edema associated with DME.
About Alimera Sciences Inc.
Alimera Sciences Inc. specializes in the development and commercialization of over-the-counter and prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences' products address both the anterior (front) and posterior (back) segments of the eye. In August 2004, Alimera Sciences unveiled Soothe(R), the market's first multi-dose, emollient-based artificial tear product.
About Control Delivery Systems, Inc.
Control Delivery Systems, Inc. develops innovative, sustained-release, drug delivery products to treat severe and chronic diseases that currently have limited or no effective treatment options. CDS has a strong history of developing drug delivery devices for the back of the eye, including one product for cytomegalovirus retinitis, a blinding eye disease primarily afflicting late-stage AIDS patients, and Retisert(TM), which was recently approved by the FDA to treat non-infectious uveitis affecting the posterior segment of the eye. CDS, a privately held company, is headquartered in Watertown, MA.
Vitrasert(R) and Retisert(TM) are trademarks of Bausch & Lomb Incorporated.
Alimera Sciences Inc.