Alimera Sciences Inc., a privately held ophthalmic pharmaceutical company, and pSivida Limited, announced that enrolment is completed for the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study of Medidur FA for the treatment of Diabetic Macular Edema. FAME is a double masked, randomised, multi-centre study that is following over 900 patients in the US, Canada, Europe and India for 36 months with safety and efficacy assessed at two years.
Alimera Sciences and pSivida are jointly developing Medidur FA under a collaborative research and development agreement, said a company press release.
"Alimera Sciences is very excited to have completed enrolment in the FAME Study as this brings us closer to taking Medidur FA, the next generation of retinal drug delivery, to market and to our ultimate goal of delivering treatments that enrich patients' quality of life," said, Dan Myers, CEO, Alimera.
Medidur, a tiny, injectable insert, is being studied as a way to deliver 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 injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.
"This marks an important milestone for the company in our profit sharing collaboration with Alimera. We are very pleased at the continued development of Medidur FA, based on our technologies that have already been approved for two back of the eye diseases. We are optimistic that Medidur FA will offer a solution to the large market we see for this product," said, Dr Paul Ashton, Managing Direct, pSivida Limited.
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. More than 500,000 people live with DME in the United States and this number is expected to exceed 700,000 by the year 2010. Currently there are no FDA approved drug treatments for DME.
Alimera Sciences Inc., a venture backed company, specializes in the development and commercialisation of prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences products are focused on improving the delivery of therapeutic agents to enhance patients' lives and strengthen physicians' ability to manage ocular conditions
pSivida is a global drug delivery company committed to the biomedical sector. Retisert is FDA approved for the treatment of uveitis. Vitrasert is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert and Retisert. pSivida has licensed the technologies underlying both of these products to Bausch & Lomb.