Alimera Sciences, a privately held ophthalmic pharmaceutical company, and global drug delivery company pSivida Limited has announced that enrolment for their phase III global clinical trial, the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) study has exceeded 50 per cent.
FAME is a double masked, randomised, multi-centre study that will follow approximately 900 patients in the US, Canada, Europe and India for 36 months. The trial is studying the safety and efficacy of the novel treatment currently referred to as Medidur for diabetic macular edema (DME).
Medidur, a tiny, injectable intravitreal insert, is being studied as a way to deliver a very low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge transconjunctival injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.
"Reaching this milestone in the FAME trial is a significant accomplishment for Alimera as we continue our efforts to bring this next generation of retinal drug delivery to market," said Dan Myers, CEO of Alimera Sciences.
"pSivida is delighted with the progress being made in this trial and we expect successful completion of enrolment later this year," said Dr Paul Ashton, managing director of pSivida Limited.
Alimera Sciences and pSivida Limited announced in February 2005 a worldwide agreement to co-develop and market the insert for the use of fluocinolone acetonide to treat DME. The agreement also includes the option to identify, prior to February 2008, three other compounds not previously licensed by pSivida to a third party for use in Medidur for ophthalmic diseases. This option has the potential to result in a license to three additional products with the Medidur insert for Alimera. Pfizer also recently reached an agreement with pSivida to commit up to US$155 million for development related to different ophthalmic applications of the Medidur technology.
"As our work continues, we are pleased with recent announcements underscoring the development interest and commitments by companies like Pfizer for this technology," said Myers. "It reinforces the confidence that we have in the technology as well."
Diabetic retinopathy (DR), a complication of diabetes mellitus, is the leading cause of blindness in the working-age population of developed countries. At any time during progression of diabetic retinopathy, patients can develop DME, which involves retinal thickening of the macular area. There are currently more than 500,000 people with DME in the United States and this number is expected to exceed 700,000 by the year 2010; approximately 75,000 new cases of DME are diagnosed each year.