Safety board recommends continuation of Alimera/pSivida trial

Medidur is a tiny, injectable device 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 data safety monitoring board (DSMB) met March 16, 2006 to review the Medidur phase III clinical trial data. After reviewing the preliminary safety data from the initial US patients enrolled in the trial, the DSMB agreed that patient enrollment should accelerate under the current protocol.

DME, a common complication of diabetic retinopathy, is the leading cause of vision loss in people under the age of 65 in the US, where it impacts an estimated 500,000 people. It is caused by a fluid build-up in the central vision portion of the retina.

At present, 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 recent clinical evidence that corticosteroids reduce edema associated with DME.

“We are very pleased with the DSMB’s conclusions and see this as a positive step toward the development of this novel treatment for DME,” said Dan Myers, CEO of Alimera. “We will now expand this phase of the masked, randomized, multi-center clinical trial in the US, Canada, Europe and India.”

In related news, pSivida also announced that, following an independent audit of its Boston, Massachusetts facility by a European qualified person (QP), the QP issued a certificate stating that Medidur is manufactured to a standard of good manufacturing practice (GMP) equivalent to that in the European Union.