pSivida in international clinical trials for eye disease treatment

Western Australian-headquartered bio-tech company pSivida Ltd and its development partner US group, Alimera Sciences Inc., have announced the approval of clinical trials of the MedidurTM device for the treatment of eye disease.

Medidur is a tiny injectable device that delivers the steroid fluocinolone acetonide directly to the back of the eye.

Regulatory agencies in the UK, Canada and India have approved trials of pSivida's device for the treatment of diabetic macular edema (DME), which is a common, blinding eye disease and a leading cause of vision loss in people under the age of 65 worldwide.

The new international clinical sites are opening in conjunction with the sites already underway in the US.

The Medidur development plan has already been granted fast-track status in the US by the Food and Drug Administration.

DME affects approximately 10 per cent 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 fluocinolone acetonide 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 (at three years) provide a clinically significant increase in many patients vision*.

*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.

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MedidurTM Diabetic Macular Edema Programme: Government Approvals for International Clinical Phase III Trials
Studies to begin in UK, Canada and India
Boston, MA., Perth, Australia and Atlanta GA - Global bio-nanotech company pSivida Limited
(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."

NOTES TO EDITORS:
*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.
pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and 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 2001 from the UK Government's Defence Evaluation & Research Agency
(DERA). QinetiQ (QQ.) was instrumental in discovering BioSiliconTM and pSivida enjoys a strong relationship
with, including access to its cutting edge research and development facilities.

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.
www.alimerasciences.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: failure to complete negotiations for new
centers for the BrachySil™ phase IIb clinical trial for inoperable primary liver cancer; failure of our discussions with the
FDA for BrachySil™ to continue or to lead to FDA approval; failure of the BrachySil™ phase IIb clinical trial for
inoperable primary liver cancer to determine the optimal dose, provide key safety data or support future pivotal
efficacy trials or product registration or approval; failure of the BrachySil™ primary liver programme that is in phase IIb
clinical trials to provide a valuable platform for the development and commercialisation of BrachySil™ for pancreatic
cancer and other indications; failure to commence phase IIa BrachySilTM trials for the treatment of pancreatic cancer;
failure of the findings of the pancreatic cancer phase IIa trial to provide a platform for further multicentre efficacy and
safety trials; failure of there to be optimisation and standardisation between the two pancreatic cancer study centres;
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; failure of Medidur™ to release fluocinolone acetonide at the
same rate as Retisert™; our inability to recruit patients for the phase III Medidur™ for DME trial; failure to develop
applications for BioSiliconTM due to regulatory, scientific or other issues; our inability to successfully integrate Control
Delivery Systems, Inc.'s operations and employees; failure of the pSivida Inc's products to achieve expected
revenues; our inability to develop existing or proposed products; failure of the Bausch & Lomb/Novartis co-promotion
arrangement to provide faster royalty growth; failure of our evaluation agreements to result in license agreements;
failure to achieve cost savings generally; and failure to execute on U.S. growth strategy. Other reasons are contained
in cautionary statements in the Annual Report 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.