) announced that its partner
Alimera Sciences Inc.
) has successfully conducted labeling discussions with the U.S.
Food and Drug Administration (FDA) related to Iluvien for the
treatment of Diabetic Macular Edema (DME).
The regulatory body and Alimera concurred that there is no
need to conduct the Dermatologic and Ophthalmic Advisory
Committee meeting for evaluating Iluvien for DME. The meeting was
scheduled to take place in Jan 2014.
We note that Alimera had suffered a setback in Oct 2013 when
it received the third Complete Response Letter (CRL) from the
FDA. The FDA refused to approve the New Drug Application (NDA)
for Iluvien in its present form. In the CRL, the FDA had
indicated that results from a new study were required to be
submitted along with a minimum of 12 months of follow-up for all
enrolled patients. The FDA also talked about deficiencies at the
manufacturing facility for Iluvien.
Alimera will respond to the CRL in the first quarter of 2014
regarding issues relating to the manufacturing facility and the
latest safety data from patients in the UK and Germany.
The FDA has now indicated that new studies will not be
required in connection with the FDA's review of Iluvien for DME
prior to approval.
Iluvien is expected to be resubmitted in the first quarter.
Once approved, pSivida will get a $25 million milestone payment
from Alimera along with 20% of net profits on U.S. sales of
Iluvien for DME.
pSivida's Iluvien is approved and marketed in the UK and
Germany, while in France it is slated to be launched early in
pSivida currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
Jazz Pharmaceuticals plc
), each carrying a Zacks Rank #1 (Strong Buy).
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