Perth-headquartered global bio-nanotech company pSivida Ltd has announced results of trials by Bausch & Lomb to evaluate pSivida Ltd's RetisertTM implant for the treatment of diabetes related eye damage.
Perth-headquartered global bio-nanotech company pSivida Ltd has announced results of trials by Bausch & Lomb to evaluate pSivida Ltd's RetisertTM implant for the treatment of diabetes related eye damage.
RetisertTM is used in the management of diabetic macular edema, which is a leading cause of vision loss for people under the age of 65, where retinal blood vessels in diabetics' eyes deteriorate and leak, causing the retina to swell.
Bausch & Lomb is the exclusive licensee of RetisertTM and conducted the studies in hospitals in the United States, on 277 patients. The trial results were presented at a recent ocular pharmacology and therapeutics symposium in Berlin.
The two year trial results demonstrated that 30 per cent of eyes receiving standard care (repeat laser treatment) had a worsening of their condition, compared with only 10 per cent of eyes receiving a RetisertTM implant.
RetisertTM was also found to reduce retinal thickening involving the fovea, and led to a statistically significant three line improvement in vision.
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RetisertTM slows progression of Diabetic Retinopathy in Diabetic Macular Edema trials
Perth, Australia and Boston, MA - Global bio-nanotech company pSivida Limited
(NASDAQ:PSDV, ASX:PSD, Xetra:PSI) today announced additional two year trial results of
Bausch & Lomb's two randomized trials to evaluate the safety and efficacy of the RetisertTM
implant in releasing fluocinolone acetonide in the management of Diabetic Macular Edema
(DME). Bausch & Lomb, exclusive licensee of RetisertTM from pSivida conducted the studies in
hospitals in the United States involving 277 patients. The trial results were presented at the
prestigious 6th International Symposium on Ocular Pharmacology and Therapeutics in Berlin
that commenced on 30 March 2006 http://www.kenes.com/isopt/index.asp.
The two year trial results demonstrated that 30% of eyes receiving standard of care (repeat
laser treatment) had a worsening of their Diabetic Retinopathy compared with only 10% of eyes
receiving a RetisertTM implant. This was statistically significant. RetisertTM also reduced retinal
thickening involving the fovea (the centre most part of the macula responsible for sharp, central
vision) and led to a statistically significant three line improvement in vision.
Diabetic Retinopathy (DR) is the leading cause of vision loss of people
in the United States under the age of 65 with an estimated 1,000,000
treatable cases. DR occurs when diabetes damages the tiny blood
vessels inside the retina, the light-sensitive tissue at the back of the
eye. DR usually affects both eyes. Currently the only FDA approved
treatment is laser therapy in which holes are burned into the macula
with a laser. This treatment is often ineffective or generally provides
only temporary benefit. DME is a common complication of DR. There
are no approved drug therapies for the treatment of either DME or
DR.
"We believe the finding that sustained release fluocinolone acetonide can slow or reduce the
progression of Diabetic Retinopathy is important and may have significant implications for
RetisertTM and MedidurTM," said Mr Gavin Rezos, CEO of pSivida Limited.
pSivida receives royalties on Retisert™ sales. Retisert™ is presently priced at US$18,250 and
is approved as a 30 month treatment for chronic non-infectious posterior segment uveitis, a
sight threatening condition that affects an estimated 175,000 people in the United States and an
estimated 800,000 people worldwide. Covered in the United States by Medicare and Medicaid,
Retisert™ is co-marketed in the United States by Bausch & Lomb and Novartis.
Three year results of the Retisert™ in DME trial will be presented at ARVO conference in May
2006 www.arvo.org.
NOTES TO EDITORS:
What is Diabetic Retinopathy? Diabetic Retinopathy occurs when diabetes damages the tiny blood
vessels inside the retina, the light-sensitive tissue at the back of the eye. A healthy retina is necessary
for good vision. Diabetic Retinopathy usually affects both eyes.
What is Diabetic Macular Edema? Diabetic Macular Edema, a
subset of diabetic retinopathy, is a leading cause of vision loss for
Americans under the age of 65. Retinal blood vessels in diabetic's
eyes deteriorate and leak, causing the retina to swell. A minority of
cases receive long-term benefit from laser treatment.
What is Uveitis? An autoimmune condition, uveitis manifests itself
as an inflammation inside the eye, that can lead to sudden or
gradual vision loss.
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 AIDSrelated
CMV Retinitis. Bausch & Lomb own the registered 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 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: the failure of the results of the Retisert for DME trial to be a good indicator of the results of
pSivida's ongoing Phase III Medidur™ for DME trial; failure of the Medidur™ trials in DME to show a very similar improvement
in visual acuity and diabetic retinopathy severity score as Retisert™ for DME; inability to recruit patients for the Phase III
Medidur™ for DME trial; 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; failure of the slower progression or reduction of diabetic retinopathy
resulting from the Retisert™ implant to have significant implications for Retisert™ and Medidur™. 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 forwardlooking
statements that may be made by or on behalf of pSivida.