Human study for diabetic macular edema treatment

Steps to improve the treatment of diabetic macular edema (DME) are moving closer as two leading drugs companies launch their first human study into the absorption, distribution and metabolism of fluocinolone acetonide (FA) - a corticosteroid.

The pharmacokinetic study, led by ophthalmic pharmaceutical business Alimera Sciences and global drug delivery company pSivida, will measure the delivery of low FA doses to the retina over a three-year period, using a small injectable device known as a Medidur. The study is designed to support phase three global clinical trial, known as Fluocinolone Acetonide in Diabetic Macular Edema (FAME), by providing pharmacokinetic/pharmacodynamic correlation data from DME patients.

Sixteen patients are set for enrolment in this three-year open label study. Samples of blood and fluid in the front of the eye will be periodically taken to assess systemic and anterior chamber drug levels, respectively.

The FAME study will follow approximately 900 patients in the US, Canada, Europe and India for three years with safety and efficacy assessed at two years.

"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, chief scientific officer for Alimera. "This study will also provide information on the location of Medidur FA in the eye after insertion and drug levels in the anterior chamber."

Dr Paul Ashton, managing director of pSivida, said: "The open label PK study that has begun is designed to provide additional pharmacokinetic, safety and efficacy data next year," he said. "Additionally, by determining anterior chamber drug levels, we will gain important knowledge related to one of the key attributes of the Medidur technology, namely minimising corticosteroid levels in the front of the eye."

Both companies have a worldwide agreement to co-develop and market Medidur insert for the use of a 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 Medidur insert.