Enrollment under way for study of FA insert

Atlanta-Enrollment has begun for the first human pharmacokinetic (PK) study of fluocinolone acetonide (FA) delivered via a proprietary intravitreal insert (Medidur) to treat diabetic macular edema (DME), according to Alimera Sciences and pSivida Ltd.

The insert with the corticosteroid is being tested in a phase III global clinical trial, the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study, which will follow approximately 900 patients in the United States, Canada, Europe, and India for 3 years. Safety and efficacy will be assessed at 2 years.

The PK study is designed to support the FAME trial by providing PK/pharmacodynamic correlation data from patients with DME. Investigators plan to enroll 16 patients in the 3-year open-label study. Samples of blood and aqueous humor will be taken periodically to assess systemic and anterior chamber drug levels, respectively.

Paul Ashton, PhD, managing director of pSivida, said, "By determining anterior chamber drug levels, we will gain important knowledge related to one of the key attributes of the . . . technology, namely minimizing corticosteroid levels in the front of the eye."

The two companies have a worldwide agreement to co-develop and market the insert for the use of FA to treat DME. The agreement also includes the option to identify other compounds for ophthalmic diseases, potentially resulting in three additional products with the insert.