pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced it has been issued US patent No. 8,192,408 titled “Ocular Trocar Assembly” for a new inserter developed to facilitate administration of micro-drug delivery devices. “We are very pleased with the issuance of this US patent for our new inserter,” said Dr. Paul Ashton, president and CEO of pSivida. “We have designed it to allow the insertion of drug delivery devices, such as our Medidur™ implant, through a far smaller needle than was previously possible and to require significantly less force to administer. We anticipate using this new inserter in the planned Phase III trials of our posterior uveitis insert. “Another advantage,” Dr. Ashton continued, “is that the new inserter allows for use of larger reservoir delivery devices. Thus our Durasert technology can now be used with a larger number of drugs.” pSivida has a very strong intellectual property portfolio with more than 100 granted patents in the US, Europe, Japan, China and Australia. About pSivida Corp. pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. ILUVIEN® for the treatment of Diabetic Macular Edema (DME), which is licensed to Alimera Sciences, Inc., is pSivida’s most advanced product candidate, and based on a consensus arrived upon by the RMS and the CMS, the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) issued its Final Assessment Report that ILUVIEN for chronic DME is approvable. The MHRA, the Austrian Agency for Health and Food Safety and the Portuguese National Authority of Medicines and Health Products have granted marketing authorization to ILUVIEN for chronic DME considered insufficiently responsive to available therapies and the additional CMS marketing authorizations are expected in the coming months. An investigator-sponsored Investigational New Drug application opened for an injectable insert to treat posterior uveitis of the same design as ILUVIEN for DME, and an investigator-sponsored trial is ongoing for an injectable, bioerodible insert to treat glaucoma and ocular hypertension. pSivida’s two FDA-approved products, Retisert® and Vitrasert®, are implants that provide long-term, sustained drug delivery to treat two other chronic diseases of the retina.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT 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 anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: Alimera’s ability to obtain regulatory approval of and successfully commercialize (alone or with others) ILUVIEN for DME in the EU and delays in any such approval; actions with respect to regulatory approval of ILUVIEN for DME in the U.S.; ability to obtain additional capital; ability to attain profitability; adverse side effects; exercise by Pfizer of the Latanoprost Product option; ability to complete clinical trials and obtain regulatory approval of product candidates; further impairment of intangible assets; fluctuations in operating results; decline in royalty revenues; ability to find partners to develop and market products; termination of license agreements; competition; market acceptance of products and product candidates; reduction in use of products as a result of future guidelines, recommendations or studies; ability to protect intellectual property and avoid infringement of others’ intellectual property; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; possible influence by Pfizer; ability to pay any registration penalties; absence of dividends; and other factors 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 makes it clear that any projected results expressed or implied in such statements will not be realized.