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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® is licensed to Alimera Sciences, Inc. and utilizes the third generation of the Durasert technology.The US Food and Drug Administration (FDA) approved ILUVIEN for the treatment of diabetic macular edema (DME) for patients treated with a course of corticosteroids and did not have a significant rise in intraocular pressure (IOP).
Additionally, 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, Spain, Italy, Norway, Denmark and Sweden. Iluvien is commercially available in the U.K and Germany.
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 other 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