pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), 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. has indicated its intention to resubmit its application for ILUVIEN® for diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA). Based on a recent meeting with the FDA, Alimera intends to use data from Alimera’s two previously completed pivotal Phase III clinical trials (FAME® Study). pSivida expects the resubmission to address the issues raised by the FDA in its November 2011 Complete Response Letter (CRL) and in its recent meeting with Alimera.
pSivida anticipates the resubmission will focus on the population of patients with chronic DME considered insufficiently responsive to available therapies, the same indication for which regulatory approval for ILUVIEN has been granted in various EU countries. Alimera has not reported an expected time for resubmission.
“We are very pleased at this development in the U.S. in addition to the recent marketing authorizations in Austria, France, Germany, Portugal and the U.K.,” said Dr. Paul Ashton, President and CEO of pSivida.
Under a collaboration agreement with Alimera, pSivida granted Alimera an exclusive worldwide license to manufacture and sell ILUVIEN for the treatment and prevention of eye diseases in humans other than uveitis. Alimera agreed to fund all development costs, pay pSivida a $25.0 million milestone payment upon FDA approval of ILUVIEN and 20% of any net profits, as defined, on sales of ILUVIEN by Alimera.
In November 2011, the FDA stated in the CRL that it was unable to approve the ILUVIEN new drug application because it 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 Alimera’s clinical trials were significant and were not offset by the benefits demonstrated by ILUVIEN in these clinical trials and indicated that Alimera would need conduct two additional clinical trials.