|
ASX/MEDIA
RELEASE
|
21
February 2006
|
pSivida:
Uveitis long term trial results positive for pSivida
Second
set of follow-up trial results announced today
Global
bio-nanotech company pSivida Limited (NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced that preliminary three year follow-up data from Bausch
and Lomb’s
multi-center, randomized, dose-masked clinical trial of Retisert™
for the
treatment of chronic non-infectious posterior
segment uveitis has
been
published. Global
eye health company, Bausch and Lomb (NYSE: BOL), exclusive licensee
of
Retisert™,
conducted the study that showed the recurrence rate was significantly lower
in
eyes
receiving Retisert™
than in
non-implanted eyes. This study involved 278 patients from 27 hospitals in
the
United States and one in Singapore.
pSivida
receives royalties from sales of Retisert™ which is presently priced at
US$18,250. Covered in the United States by Medicare and Medicaid, Retisert™ is
co-marketed in the United States by Bausch & Lomb and Novartis.
|
Surgically implantable RetisertTM
|
Posterior uveitis is the third
leading cause
of blindness in the United States where it afflicts an estimated
175,000
people. Approximately 800,000 people have the disease worldwide.
Uveitis
is a chronic auto-immune disease in which the bodies own defences
attack
the inner lining of the eye (the uvea). Retisert™,
approved by the FDA in April 2005, is the only FDA approved drug
for this
disease. Retisert™ is surgically implanted into the eye and is approved to
release a constant amount of the drug, fluocinolone
acetonide,
over a treatment period of 30
months. |
The
study
concluded that at three years control of uveitis in eyes implanted with
Retisert™
was
still significantly better than in non-implanted eyes, but was less effective
than at two years and that some eyes may need to be re-implanted between
24 and
36 months.
“These
results confirm the long term benefits of Retisert™ in
the
treatment of this devastating disease,” said Mr Gavin
Rezos, CEO of pSivida Limited. “The possible need for an additional implant at
between 24 and 36 months is consistent with the 30 month label from the FDA”.
In
this
study, patients were randomised to receive either a 0.59 mg or a 2.1 mg
Retisert™ device. Data presented was the aggregate of the two doses. At three
years, the recurrence rate of uveitis was 33% in the eye receiving Retisert™
compared to 57% of fellow eyes (p< 0.001). A greater number of eyes receiving
Retisert™ experienced an improvement in vision of at least 15 letters (three
lines on an eye chart) compared to fellow eyes (22% versus 6%, p<0.001). 45%
of eyes receiving Retisert™ required an operation to relieve elevated
intraocular pressure and 92% developed a cataract. Cataract
surgery is a relatively uncomplicated and established procedure with a high
success rate.
The
abstract (#1523) detailing this data is available on the website of the
Association for Research in Vision and Ophthalmology www.arvo.org.
Fuller
data will be presented at the ARVO conference in May 2006.
-ENDS-
|
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 943 1100 ext. 12
bjedynak@janispr.com
|
UK
& Europe Public Relations
Mark
Swallow / Helena Podd
Citigate
Dewe Rogerson
Tel:
+44 (0)20 7638 9571
mark.swallow@citigatedr.co.uk
|
NOTES
TO EDITORS:
|
What
is Uveitis? An
autoimmune condition, Uveitis manifests itself as an inflammation
inside
the eye, that can lead to sudden or gradual vision loss. It can
be caused
by diseases such as multiple sclerosis, rheumatoid arthritis
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. The technologies underlying both of
these
products are licensed to Bausch & Lomb.
|
|
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structrured 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
Massachusetts, Malvern in the United Kingdom, Perth in Western Australia
and
Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and in
Germany on the Frankfurt Stock Exchange on the XETRA system (German Symbol:
PSI. Securities Code (WKN) 358705).
pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
The
Company's largest shareholder and a strategic partner is QinetiQ, a leading
international defence, security and technology company, formed in July 2001
from
the UK Government's Defence Evaluation & Research Agency
(DERA). QinetiQ was instrumental in discovering BioSilicon(TM)
and
pSivida enjoys a strong relationship with it having access to its cutting
edge
research and development facilities. For more information visit www.QinetiQ.com
For
more
information, visit www.psivida.com
This
document contains forward-looking statements that involve risks and
uncertainties. The statements are indicated by the use of words such
as
"believes", "expects", "anticipates" and similar words and phrases.
Although we believe that the expectations reflected in such forward-looking
statements are reasonable at this time, we can give no assurance that such
expectations will prove to be correct. Given these uncertainties, readers
are
cautioned not to place undue reliance on such forward-looking statements.
Actual
results could differ materially from those anticipated in these forward-looking
statements due to many important factors including: our failure to develop
applications for BioSiliconTM
due to
regulatory, scientific or other issues, our inability to successfully integrate
CDS’ operations and employees; the failure of the CDS’ products to achieve
expected revenues and the combined entity’s inability to develop existing or
proposed products; the failure of the Bausch & Lomb/Novartis co-promotion
arrangement to provide faster royalty growth. Other reasons are contained
in
cautionary statements in the Registration Statement on Form 20-F filed with
the
U.S. Securities and Exchange Commission, including, without limitation, under
Item 3.D, "Risk Factors" therein. We do not undertake to update any oral
or
written forward-looking statements that may be made by or on behalf of
pSivida.