Alimera/pSivida enroll 50% in Ph III Medidur trial

Alimera Sciences, a privately-held US ophthalmic pharmaceutical firm, and Australia-headquartered global drug delivery company pSivida say that enrollment for their Phase III global clinical trial, the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study has exceeded 50%. FAME is a double masked, randomized, multicenter study that will follow around 900 patients in the USA, Canada, Europe and India for 36 months. The trial is studying the safety and efficacy of the novel treatment currently referred to as Medidur for diabetic macular edema.

Medidur, a tiny, injectable intravitreal insert, is being studied as a way to deliver a very low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema. Using a proprietary 25 gauge transconjunctival injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.