pSivida Announces Last Patient in Phase III Iluvien[R] Trial Completes 2 Year Follow-Up Visit.Top Line 24-Month Results Expected Mid-December from Pivotal Phase III Trial for Potential First Drug Treatment for Diabetic Macular Edema WATERTOWN, Mass. -- pSivida Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :PSDV PSDV Process Shut Down Valve (oil & gas) )(ASX ASX See: Australian Stock Exchange :PVA PVA polyvinyl alcohol. ), a leading drug delivery company that has developed two of the only three products approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME (Distributed Management Environment) A network monitoring and control protocol defined by the Open Software Foundation (now The Open Group). DME was not widely used. DME - Distributed Management Environment ) 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any (New Drug Application) with the FDA in the second quarter of 2010," said Dr. Paul Ashton, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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[TM] 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[R]. pSivida also has two products approved by the Food and Drug Administration (FDA): Retisert([R]) for the treatment of uveitis uveitis Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness. and Vitrasert([R]) for the treatment of AIDS-related cytomegalovirus cytomegalovirus (sī'təmĕg'əlōvī`rəs), member of the herpesvirus family that can cause serious complications in persons with weakened immune systems. (CMV CMV cytomegalovirus. CMV abbr. 1. controlled mechanical ventilation 2. cytomegalovirus Cytomegalovirus (CMV) ) retinitis retinitis /ret·i·ni·tis/ (ret?i-ni´tis) inflammation of the retina. retinitis circina´ta , circinate retinitis circinate retinopathy. . 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[TM], which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil[TM], 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 Boston in the United States and Malvern in the United Kingdom. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the forward-looking statements: continued losses and lack of profitability; inability to derive revenue from Retisert; impairment of intangibles; fluctuations in the fair values of certain outstanding warrants; fluctuations in operating results; inability to raise capital; termination of license agreements; inability to obtain regulatory approvals for products; inability to obtain partners to develop and market products; competition; insufficient third-party reimbursement for products; inability to protect intellectual property or infringement of others' intellectual property; failure to retain key personnel; consolidation in the pharmaceutical and biotechnology industries; 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 Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied in such statements will not be realized. |
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