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(ASX:PSD, NASDAQ:PSDV, Xetra:PSI) and development partner Alimera Sciences Inc., are
pleased to announce that regulatory agencies in the U.K., Canada and India have approved the
commencement of Phase III clinical trials of the MedidurTM device for the treatment of diabetic
macular edema (DME). These international clinical sites are opening in conjunction with the sites
already underway in the U.S. The Medidur development plan has already been granted Fast
Track status in the U.S. by the Food and Drug Administration (FDA).
Medidur, a tiny injectable device, delivers the steroid fluocinolone acetonide (FA) directly to the
back of the eye and is designed to treat DME. DME is a common, blinding eye disease, and is a
leading cause of vision loss in people below 65 years of age worldwide. It affects approximately
10% of diabetics, with over 500,000 people in the U.S. and millions world-wide having the
disease. Presently there are no FDA approved drug treatments for DME and the standard of
care consists of laser surgery that is often ineffective and, at best, generally provides temporary
relief of symptoms.
Sustained delivery of FA to the back of the eye has previously been shown to reduce edema in
patients with DME, reduce the progression of their diabetic retinopathy, and most importantly, at
three years provide a clinically significant increase in many patients vision*. These results were
generated in a 198 patient clinical trial conducted in the U.S. with the Retisert™ product by
pSivida partner, Bausch & Lomb. Retisert, a surgically implanted device, delivers FA to the back
of the eye. It is has been approved by the FDA for the treatment of uveitis, a leading cause of
blindness in the U.S.
“Medidur is a simple injectable device that does not require surgery. We hope the Phase III
studies with the Medidur device will show similar efficacy to previous trials with sustained
release FA,” said Gavin Rezos CEO of pSivida. “We believe the initiation of the international
phase of the studies is an important milestone which will both accelerate recruitment and enable
physicians, patients, and regulatory authorities in different countries to gain experience with the
product before approval is sought.”
According to Dan Myers, CEO of Alimera Sciences Inc., “We believe that the initiation of
international clinical sites is a great achievement and a significant step for our two companies.”
*Three year follow-up data from a clinical trial of sustained release Fluocinolone acetonide (FA) in 198
patients with DME was presented at the annual ARVO conference in May 2006. At 3 years more
patients receiving sustained release FA had an improvement in vision of 3 lines compared with those
receiving standard of care (laser). This was statistically significant (p < 0.05). Also at 3 years, more
patients receiving FA had a complete resolution of their edema compared with those receiving laser (p
< 0.05). At 2 years ( the last time point for which a complete data set exists) more patients receiving
FA also had stable or improved diabetic retinopathy compared with those receiving laser (p < 0.05).
About pSivida Limited
pSivida is a global bio-nanotech company committed to the biomedical sector and the development of
drug delivery products. 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. The technology underlying Medidur™, a treatment for diabetic macular edema, is
licensed to Alimera Sciences and is in Phase III clinical trials.
pSivida owns the rights to develop and commercialise a modified form of silicon (porosified or nano-
structured silicon) known as BioSilicon™, which has applications in drug delivery, wound healing,
orthopaedics, and tissue engineering. pSivida’s subsidiary, AION Diagnostics Limited is developing
diagnostic products and the subsidiary pSiNutria is developing food technology products both using
BioSilicon™.
pSivida’s intellectual property portfolio consists of 70 patent families, 74 granted patents and over 290
patent applications. pSivida conducts its operations from offices and facilities near Boston in the
United States, Malvern in the United Kingdom, Perth in Australia and Singapore.
For more information, visit www.psivida.com
About Alimera Sciences Inc.
Alimera Sciences Inc. specializes in the development and commercialization of over-the-counter and
prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive
development and revenue growth expertise, Alimera Sciences’ products address both the anterior
(front) and posterior (back) segments of the eye, as well as underserved and overlooked areas of the
ophthalmic market. The company is headquartered in Alpharetta, Georgia.
For more information, visit www.alimerasciences.com
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