) 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
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
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.
) 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
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 &
pSivida carries a Zacks Rank #2 (Buy). Right now,
Biogen Idec Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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