ATLANTA--(BUSINESS WIRE)--Alimera Sciences, a privately held ophthalmic pharmaceutical company, and pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) today announced that enrollment has begun for the first human (a)pharmacokinetic (PK) study of fluocinolone acetonide (FA) in Medidur™, the companies’ investigational product for the treatment of diabetic macular edema (DME).
Medidur is a tiny insert, injected intra-vitreally during an in-office procedure, which is being studied as a way to deliver a very low dose of fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years as a treatment for DME. Medidur FA is currently in a Phase III global clinical trial, the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study that will follow approximately 900 patients in the U.S., Canada, Europe and India for three years with safety and efficacy assessed at two years. Enrollment for this study has currently exceeded 750 patients.
