ABOUT / OVERVIEW
Focused Therapeutics / Visionary Science
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 three of the only four products approved by either the US or EU for the long-term, sustained-released delivery of drug to treat chronic eye disease.
Our most recently approved product, ILUVIEN® for diabetic macular edema (DME), has received marketing authorization in the UK, Austria, France, Germany, Portugal, and Spain with an approval in Italy anticipated in the coming months. These marketing authorizations followed a positive outcome of the European Decentralized Procedure involving these seven countries. ILUVIEN, licensed to Alimera Sciences, Inc. (Alimera), is approved for use in the treatment of vision imparement associated with chronic DME considered insufficiently responsive to available therapies.
ILUVIEN is a tiny device that provides sustained release of the drug fluocinolone acetonide for approximately 3 years. By injecting it directly into the back of the eye, the drug is released in its site of action, eliminating risks of systemic exposure. ILUVIEN uses a third generation of Durasert, our miniature sustained release drug delivery technology.
In addition to the application of this product in DME licensed to Alimera, pSivida is independently developing the product for the treatment of posterior uveitis. The FDA recently cleared the Company's Investigational New Drug (IND) application to treat posterior uveitis with our injectable, sustained-release micro-insert, permitting pSivida to move directly to two Phase III trials under which we would enroll a total of 300 patients. The FDA is allowing pSivida to reference much of the data, including the clinical safety data, from the clinical trials of ILUVIEN for DME previously conducted by Alimera. Under the terms of our collaboration agreement with Alimera, pSivida has joint ownership of, and reference rights to, all clinical data and regulatory filings generated by Alimera, including its New Drug Application (NDA) for DME.
pSivida's two FDA-approved sustained release products to treat chronic back-of-the-eye diseases are Retisert® for the treatment of posterior uveitis and Vitrasert for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products to Bausch & Lomb Incorporated. Vitrasert and Retisert provide sustained release for six to nine months and two and a half years, respecively.
pSivida has a worldwide Collaborative Research and License agreement with Pfizer Inc. to develop a long-term, sustained release implant to deliver latanoprost for patients with ocular hypertension and glaucoma. This collaboration is focused on developing a bioerodible version of pSivida's proprietary Durasert® technology designed to be injected into the subconjunctival space of the eye.
pSivida is developing a series of additional miniaturized, bioerodible, sustained release systems to deliver a range of proteins and small drug molecules to virtually any site in the body. One of these systems is Tethadur®, a nanostructured, bioerodible material.
pSivida's intellectual property portfolio consists of over 150 issued patents in countries including the U.S., Europe, Japan, China and Australia. pSivida, a NASDAQ listed company (PSDV), is developing products designed to revolutionize treatments, with a primary focus in ophthalmology.