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pSivida develops tiny, sustained-release drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. We have developed three of the four products approved in either the U.S. or the EU for sustained release delivery of drug to treat chronic back-of-the-eye diseases utilizing multiple generations of our Durasert™ technology system.
Our lead development product, ILUVIEN® for the treatment of diabetic macular edema (DME) is licensed to Alimera Sciences, Inc. and utilizes the third generation of the Durasert technology. ILUVIEN received a positive outcome from the EU Decentralized Procedure in February 2012 with a determination that ILUVIEN is approvable for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Following this determination, ILUVIEN has received formal marketing authorization in the U.K., Austria, Portugal, France, Germany and Spain and we anticipate marketing authorization to be issued in the other participating EU country (Italy) during the upcoming year. Alimera has reported that it plans to commercialize ILUVIEN for DME in Germany in the second quarter of 2013 with its European management now team onboard.
An investigator-sponsored Investigational New Drug (IND) application is open for an injectable insert of the same design as ILUVIEN to treat posterior uveitis and an investigator-sponsored trial is ongoing for an injectable, bioerodible insert to treat glaucoma and ocular hypertension under our amended collaboration agreement with Pfizer, Inc.
pSivida’s two FDA-approved products, Retisert® and Vitrasert®, licensed to Bausch & Lomb, Inc., are implants utilizing earlier generations of our Durasert technology system that provide long-term, sustained drug delivery to treat two other chronic diseases of the retina.
Martin E. Janis & Company
Computershare Investor Services
P.O. Box 43078
Providence, RI 02940 USA