New Medidur study begins

Alimera Sciences and pSivida have announced that enrolment has begun for the first human pharmacokinetic study of fluocinolone acetonide (FA) in Medidur, the companies' product for the treatment of diabetic macular oedema (DME).

Medidur FA is already undergoing a Phase III clinical trial (FAME Fluocinolone Acetonide in Diabetic Macular Edema) which will follow 900 patients across the US, Canada, Europe and India for three years, with safety and efficacy being assessed at two years.

The pharmacokinetic study will support the FAME trial by providing pharmacokinetic/pharmacodynamic correlation data from DME patients.Medidur is a non-erodible, intravitreal device small enough to be injected into the vitreous of the eye. It provides steady fluocinolone acetonide delivery to the back of the eye for up to three years.