Medidur trial completes enrolment

Alimera Sciences and pSivida have completed enrolment for the FAME (Fluocinolone Acetonide in diabetic Macular Edema) study of Medidur.

FAME is a double-masked, randomized, multicentre study that has now enrolled 900 patients across the US, Canada, Europe and India and will assess the safety and efficacy of Medidur for the treatment of diabetic macular oedema (DME).

An independent Data Safety Monitoring Board (DSMB) has recently recommended that the pivotal Phase III clinical trial continue under the current protocol, without change.

Medidur is a tiny, injectable insert that delivers fluocinolone acetonide, a corticosteroid, to the retina for up to three years.