pSivida Announces Last Patient in Phase III Iluvien(R) Trial Completes 2 Year Follow-Up Visit
“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
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
About
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
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida has completed an initial safety clinical trial of BrachySil for the treatment of pancreatic cancer and is nearing completion of a follow-on dose-ranging clinical trial.
pSivida’s intellectual property portfolio consists of 62 patent
families, over 100 granted patents, including patents accepted for
issuance, and over 200 patent applications. pSivida conducts its
operations from
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ACT OF 1995: Various statements made in this release are
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others’ intellectual property; failure to retain key personnel;
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failure to comply with laws and regulations; manufacturing problems;
risks and costs of international business operations; volatility of
stock price; possible dilution through exercise of outstanding warrants
and stock options; possible influence by Pfizer; payment of registration
penalties; nonpayment of dividends; and other factors that may be
described in our filings with the
Source:
For pSivida Corp.
In US: Beverly Jedynak
312-943-1123
bjedynak@janispr.com
In
Australia: Brian Leedman, Vice President for Australian Investor
Relations
pSivida Corp.
+61 8 9227 8327
brianl@psivida.com
