Back to top

Analyst Blog

pSivida Corp.  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 2014.

pSivida currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals plc (JAZZ - Analyst Report), each carrying a Zacks Rank #1 (Strong Buy). 

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
SYNAPTICS I… SYNA 78.11 +8.14%
CENTURY ALU… CENX 19.88 +5.74%
GREEN PLAIN… GPRE 39.41 +5.12%
PILGRIM'S P… PPC 28.82 +3.08%
THE PANTRY… PTRY 18.41 +2.79%