Medidur Trial Exceeds 500 Patient Mark In Phase 3 Trial Enrollment
Alimera Sciences, a privately held ophthalmic pharmaceutical company, and global drug delivery company pSivida Limited announced that enrollment for their Phase 3 global clinical trial, the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study has exceeded 50 percent.
FAME is a double masked, randomized, multi-center study that will follow approximately 900 patients in the U.S., 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 (DME).
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 (DME). 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.
"Reaching this milestone in the FAME trial is a significant accomplishment for Alimera as we continue our efforts to bring this next generation of retinal drug delivery to market," said Dan Myers, CEO of Alimera Sciences.