Shares of pSivida Corp. (PSDV) gained 4.14% on Jul 15, 2013, on the announcement of encouraging interim data from an investigator-sponsored phase I/II study of the company’s injectable micro-insert in patients with posterior uveitis.
As per information provided by pSivida, around 175,000 people in the US suffer from posterior uveitis, resulting in an estimated 30,000 cases of blindness.
Interim data (through the first 12 months of the three-year study) revealed that none of the treated eyes had a recurrence of uveitis, and inflammation was reduced in all treated eyes as compared to untreated eyes. The micro-inserts were well-tolerated and the safety profile was consistent with the safety profile in studies of Iluvien in diabetic macular edema (:DME).
Earlier this month, pSivida commenced the first of two planned phase III pivotal studies for its micro-insert in this indication. The candidate will use pSivida’s Durasert technology. Primary endpoints of these trials are recurrence of posterior uveitis at 12 months. The company said that it will be allowed to use a major part of the data, including safety data, from phase III studies of Iluvien for the treatment of chronic DME.
We note that pSivida has collaborated with Alimera Sciences, Inc. (ALIM) to develop Iluvien for DME. Iluvien is approved in the UK, Austria, France, Germany, Portugal and Spain, while in Italy it has been recommended for approval. In the first quarter of 2013, Alimera resubmitted a New Drug Application (:NDA) to the US Food and Drug Administration (:FDA) for Iluvien after having received a second Complete Response Letter in Nov 2011 from the regulatory body. The FDA will respond to the NDA by Oct 17, 2013. pSivida has not licensed Alimerathe rights to use this micro-insert for the treatment of uveitis.
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