Alimera Sciences Inc. and Control Delivery Systems Inc. (CDS) began a phase III clinical trial to study patients with diabetic macular edema (DME) treated using the Medidur implant to deliver fluocinolone acetonide.
The masked, randomized, multicenter study will follow 900 patients in the United States and Europe for 36 months. The Medidur implant, injected through a needle during an in-office procedure, is expected to provide sustained delivery of fluocinolone acetonide to the back of the eye for up to 3 years, according to Alimera Sciences.
"Advanced therapies require innovative methods of delivery, and Medidur fits that model," said Dan Myers, president and chief executive officer of Alimera Sciences, Alpharetta, GA. "The Alimera Sciences team is delighted to reach this critical product development milestone with CDS at such a stage of our company's progression. We anticipate that Medidur technology will allow eye-care professionals to provide their DME patients with an effective and long-lasting therapeutic treatment."