pSivida is a leading provider of miniaturized, sustained-release drug delivery products and is continuing the evolution of these systems.
Our proven proprietary technologies enable us to achieve highly focused long-term delivery of therapeutics. We have developed two of the three products approved by the FDA for the long-term sustained-release delivery of drug to treat chronic eye disease.
Our lead development product ILUVIEN® is under FDA review for the treatment of Diabetic Macular Edema (DME). This delivery device is designed to provide sustained release of fluocinolone acetonide (FA) directly into the back of the eye for up to three years after a single injection. Three year safety and efficacy results from two independent Phase III clinical trials were submitted as part of the NDA in May 2011 and we anticipate a decision from the FDA in late 2011. ILUVIEN utilizes Medidur™, our third generation miniature sustained release drug delivery technology.
pSivida, a NASDAQ listed company, is developing products designed to revolutionize treatments in critical areas such as ophthalmology, oncology and cardiology.