pSivida Corp. (PSDV) recently commenced the first of two planned phase III pivotal studies for its micro-insert for the treatment of chronic, non-infectious posterior uveitis. The candidate will use pSivida’sDurasert technology.
The US Food and Drug Administration (:FDA) cleared pSivida’sinvestigational new drug (IND) application and gave pSivida permission to move this candidate directly into phase III.
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.
Primary endpoints of these trials will be 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 diabetic macular edema (:DME).
We note that pSivida had 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) for Iluvien after having received a second Complete Response Letter in Nov 2011 from the FDA. 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.
pSivida expects to achieve an efficacy level similar to that observed in phase III studies for Retisert but with the same side effect profile observed in phase III studies for Iluvien. We note that Retisert is an FDA approved drug of pSivida for the treatment of posterior uveitis and is licensed to Bausch & Lomb.
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