(Source: Business Wire)
pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leading drug delivery company
that has developed two of the only three products approved by the FDA
for the long-term, sustained release delivery of drug to treat chronic
back of the eye disease, today announced that the last patient in the
Phase III clinical trial being conducted by its collaborative partner,
Alimera Sciences, for a new treatment for diabetic macular edema (DME)
has completed the two-year follow up visit. The Phase III studies
compare two doses of Iluvien with sham treatment.
"We are very pleased that this important milestone has been achieved and
we expect to see top-line 24-month data from the trial in mid-December.
Assuming positive data, Alimera expects to file the NDA (New Drug
Application) with the FDA in the second quarter of 2010," said Dr. Paul
Ashton, CEO of pSivida.
Iluvien is an investigative, extended release intravitreal insert
currently under development for the treatment of Diabetic Macular Edema
(DME). Each Iluvien insert is designed to provide a sustained
therapeutic effect of up to 36 months, for the low dose Iluvien, and up
to 24 months, for the high dose of Iluvien. Iluvien is inserted into a
patient's eye with a needle two thousandths of an inch in diameter,
which allows for a self-sealing wound. This insertion is very similar to
an intravitreal injection, a procedure commonly employed by retinal
specialists. An NDA for Iluvien is expected to be filed with the FDA in
the second quarter of 2010 by Alimera.
About pSivida Corp.
pSivida is a world leader in the development of tiny, sustained release,
drug delivery products that are administered by implantation, injection
or insertion. pSivida's lead development product delivers fluocinolone
acetonide (FA) for the treatment of diabetic macular edema (DME). This
product candidate, formerly known as Medidur FA for DME, is licensed to
Alimera, which is conducting fully recruited Phase III clinical trials
and intends to commercialize the product under the name Iluvien®.
pSivida also has two products approved by the Food and Drug
Administration (FDA): Retisert® for the treatment of uveitis
and Vitrasert® for the treatment of AIDS-related
cytomegalovirus (CMV) retinitis. pSivida has licensed both of these
products and the technologies underlying them to Bausch & Lomb
Incorporated. pSivida has a worldwide collaborative research and license
agreement with Pfizer Inc. under which Pfizer may develop additional
ophthalmic products.
pSivida owns the rights to develop and commercialize a modified form of
silicon known as BioSilicon, which has potential therapeutic
applications.
