Enrollment begins for study of FA insert for DME

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 pharmacokinetic/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.

“Enrolling the same population in this study as in our FAME trial for DME will provide another important opportunity to learn more about the effect of FA on various aspects of this condition, as well as assess systemic drug levels,” said Ken Green, PhD, chief scientific officer for Alimera, a privately held ophthalmic pharmaceutical company. “This study will also provide information on the location of [the implant] in the eye after insertion and drug levels in the anterior chamber.”

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.