Perth-based biotechnology company pSivida Ltd has commenced enrolment for the first studies of absorption, distribution and metabolism of its diabetic macular edema treatment Medidur, the company has announced.
Perth-based biotechnology company pSivida Ltd has commenced enrolment for the first studies of absorption, distribution and metabolism of its diabetic macular edema treatment Medidur, the company has announced.
The full text of a company announcement is pasted below
ATLANTA, August 22, 2007-- Alimera Sciences, a privately held ophthalmic pharmaceutical company, and pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI) today announced that enrollment has begun for the first human *pharmacokinetic (PK) study of fluocinolone acetonide (FA) in Medidur™, the companies' investigational product
for the treatment of diabetic macular edema (DME).
Medidur is a tiny insert, injected intra-vitreally during an in-office procedure, which is being studied as a way to deliver a very low dose of fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years as a treatment for DME. Medidur FA is currently in a Phase III global clinical trial, the FAME™ (Fluocinolone Acetonide in
Diabetic Macular Edema) Study that will follow approximately 900 patients in the U.S., Canada, Europe and India for three years with safety and efficacy assessed at two years.
Enrollment for this study has currently exceeded 750 patients.
This PK study is designed to support the FAME trial by providing pharmacokinetic/pharmacodynamic correlation data from DME patients. Sixteen patients are planned to be enrolled in this three-year, open label study. Samples of blood and aqueous humor (the fluid in the front of the eye) will be periodically taken 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. "This study will also provide information on the location of
Medidur FA in the eye after insertion and drug levels in the anterior chamber."
Alimera Sciences and pSivida Limited have a worldwide agreement to co-develop and market the Medidur 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 Medidur insert.
"The open label PK study that has begun is designed to provide additional pharmacokinetic, safety and efficacy data next year," said Dr Paul Ashton, PhD, Managing Director of pSivida Limited. "Additionally, by determining anterior chamber drug levels, we will gain important knowledge related to one of the key attributes of the Medidur technology, namely minimizing corticosteroid levels in the front of the eye."
*The study of absorption, distribution, metabolism and excretion of a drug.
