Healthcare Industry News: fluocinolone acetonide
News Release - March 20, 2006
Data Safety Monitoring Board Recommends Continuation of Medidur(TM) Phase 3 Clinical TrialATLANTA AND BOSTON, March 20 (HSMN NewsFeed) -- Alimera Sciences Inc., an emerging ophthalmic pharmaceutical company, and pSivida Limited, a global bio-nanotech company, announced today that following a planned interim review, an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of its Phase 3 clinical trial of Medidur(TM).
The DSMB met March 16, 2006 to review the Medidur Phase 3 clinical trial data. Medidur(TM), a tiny, injectable device, 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).
After reviewing the preliminary safety data from the initial U. S. patients enrolled in the Medidur(TM) trial, the DSMB agreed that enrollment should accelerate in the Phase 3 trial under the current protocol. A DSMB provides independent evaluation of study data to identify potential safety issues that might warrant modification or early termination of ongoing studies.
"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 Sciences. "We will now expand this phase of the masked, randomized, multi-center clinical trial in the U.S., Canada, Europe and India."
Gavin Rezos, CEO of pSivida, commented, "We anticipate Medidur(TM) will provide DME patients with a safe, effective and long-lasting therapeutic treatment that can be provided non-surgically by eye care professionals in their offices."
DME, a common complication of diabetic retinopathy, is the leading cause of vision loss in people under the age of 65 in the U.S. 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.
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, as well as underserved and overlooked areas of the ophthalmic market. The company is headquartered in Alpharetta, Georgia.
About pSivida Limited
pSivida Limited is a global bio-nanotech company committed to the biomedical sector in the development of drug delivery products. pSivida conducts its operations from offices and facilities near Boston in Massachusetts, Malvern in the United Kingdom, Perth in Australia and Singapore.
Source: Alimera Sciences
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