Medidur™

In February 2005, Alimera Sciences and CDS (now pSivida Limited) announced a worldwide agreement to co-develop and market Medidur using fluocinolone acetonide to treat diabetic macular edema (DME). 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).

The Medidur™ insert (see picture) is only 3mm in length and 0.37mm in diameter and is delivered via a 25 gauge injector system. Patients will receive the Medidur insert during an in-office procedure that takes minutes and does not require any sutures.

At either .2 micrograms or .5 micrograms of drug delivered to the retina per day, Medidur will be releasing the smallest amount of drug currently available for treating DME.

A global clinical trial, the FAME (Fluocinolone Acetonide in Macular Edema) Study is a masked, randomized, multi-center study that will follow 900 patients in the U.S., Canada, Europe and
India for 36 months. The trial began in September 2005.

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 cortico steroids reduce edema associated with DME.