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FAME is a double masked, randomized, multi-center study that is followingover 900 patients in the U.S., Canada, Europe and India for 36 months insupport of a planned global registration filing, with safety and efficacyassessed after two years of follow-up. Last week, Alimera and pSividaannounced that enrollment for the FAME study is complete.
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A DSMB provides an independent evaluation of all trial data to identifypotential safety issues that might warrant modification or early terminationof ongoing studies. The FAME DSMB, a group comprised of four ophthalmologistsand a biostatistician, met to review the Medidur FA Phase 3 clinical trialdata. The DSMB's charter stipulates that a formal review occur every sixmonths in addition to their ongoing review of the trial.
"Alimera is pleased to have received the recommendation from the DSMB thatthe study proceed as planned," said Alimera CEO Dan Myers. "Thisrecommendation further indicates that the development program for Medidur FAis on track for regulatory submissions in early 2010."
Medidur, a tiny, injectable insert, is being studied as a way to deliverfluocinolone acetonide, a corticosteroid, to the retina for up to three yearsas a treatment for diabetic macular edema (DME). Using a proprietary 25 gaugeinjector system, an eye care professional injects the Medidur insert into thevitreous through a minimally invasive procedure in an outpatient setting.Currently, there are no FDA approved drug treatments for DME.
"We are very pleased that the DSMB has found no significant issues in thetreatment of patients with Medidur over the past 18 months in the recruitmentphase of this pivotal study," said pSivida Limited Managing Director, Dr. PaulAshton.
Currently, 7.5 percent of the US population is diabetic. Over time,almost all diabetics will develop some form of diabetic retinopathy, of whichdiabetic macular edema is the primary cause of vision loss. There arecurrently more than 500,000 people with DME in the United States and thisnumber is expected to exceed 700,000 by the year 2010; approximately 75,000new cases of DME are diagnosed each year.
About Alimera Sciences Inc.
Alimera Sciences Inc., an Atlanta, GA. venture backed company, specializesin the development and commercialization of prescription ophthalmologypharmaceuticals. Founded by an executive team with extensive development andrevenue growth expertise, Alimera Sciences' products are focused on improvingthe delivery of therapeutic agents to enhance patients' lives and strengthenphysicians' ability to manage ocular conditions. Alimera is currentlyconducting a Phase 3 clinical trial of fluocinolone acetonide in theMedidur(TM) drug delivery system for the treatment of diabetic macular edema.For more information, please visit http://www.alimerasciences.com
About pSivida Limited
pSivida, a Boston, MA. based global drug delivery company, is committed tothe biomedical sector. Retisert(R) is FDA approved for the treatment ofuveitis. Vitrasert(R) is FDA approved for the treatment of AIDS-related CMVRetinitis. Bausch & Lomb own the trademarks Vitrasert(R) and Retisert(R).pSivida has licensed the technologies underlying both of these products toBausch & Lomb. The technology underlying Medidur(TM) for diabetic macularedema is licensed to Alimera Sciences and is in Phase 3 clinical trials.pSivida has a worldwide collaborative research and license agreement withPfizer Inc. for other ophthalm
