FDA Rejects Iluvien
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pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for ILUVIEN® for DME
WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ: PSDV - News) (ASX: PVA.AX - News), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today reported that its licensee Alimera Sciences, Inc. (Alimera) received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ILUVIEN® for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy.
The FDA stated in the CRL that it was
unable to approve the ILUVIEN NDA because the NDA did not provide sufficient data to support that ILUVIEN is safe and effective in the treatment of patients with DME. The FDA stated that the risks of adverse reactions shown for ILUVIEN in the FAME® Study were significant and were not offset by the benefits demonstrated by ILUVIEN in these clinical trials.
The FDA stated that Alimera will need to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication. Alimera reported that it will be requesting a meeting with the FDA to clarify next steps.
“We are obviously surprised and disappointed with the FDA’s decision,” said Paul Ashton, PhD, president and chief executive officer of pSivida.
Alimera reported that for Europe, Alimera expects to submit its formal response to the Preliminary Assessment Report to the Medicines and Healthcare products Regulatory Agency (MHRA) later this month. Alimera stated that based on this submission, the MHRA is expected to make a recommendation on the approvability of ILUVIEN for DME to Alimera and the Concerned Member States (Austria, France, Germany, Italy, Portugal and Spain) by the end of this year, with a decision regarding the approval of ILUVIEN for DME expected in the first half of 2012.
Conference Call to be Held Monday
pSivida Corp. will host a live webcast and conference call Monday, November 14, 2011, at 9:00 am ET to discuss the CRL. Access information will be announced later today.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert(TM) and BioSilicon(TM).
Contact:
US Public Relations
Beverly Jedynak
President
Martin E. Janis & Company, Inc
Tel: +1 (312) 943 1123
bjedynak@janispr.com
or
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
pSivida Corp.
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