DME implant on course for 2010 approval

September 29, 2008

The two Phase III trials of Iluvien (fluocinolone acetonide; Alimera Sciences Inc) in diabetic macular oedema (DME) have been assessed for safety and efficacy by an independent Data Safety Monitoring Board and are to progress without change.

The two Phase III trials of Iluvien (fluocinolone acetonide implant; Alimera Sciences) for the treatment diabetic macular oedema (DME) have been assessed for safety and efficacy by an independent Data Safety Monitoring Board and are to progress without change. If outcomes continue to be positive, the manufacturers hope to submit the agent for approval within the next two years.

Iluvien, a therapeutic that is implanted intravitreally with a 25G needle, is available in two doses, designed to be effective for 24 and 36 months. The double-masked, multicentre trials finished enrolling patients in October 2007; the trials are designed to study the effect of the drug in patients from the US, Canada, Europe and India (n=956) for 36 months, with initial safety and efficacy follow-up at 24 months.