pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced that its licensee, Alimera Sciences, Inc., resubmitted a New Drug Application for the investigational drug ILUVIEN for the treatment of diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA) on May 12, 2011 to address questions raised in the Complete Response Letter (CRL) Alimera received in December 2010.
Alimera reported that according to the FDA’s classification scheme, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received.
This resubmission is intended to address the FDA’s request for additional analyses of safety and efficacy data though month 36 of the FAME Study. Alimera reported that data from the subgroup of patients with chronic DME presented at last week’s Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting was also provided together with additional information regarding controls and specifications on the manufacturing, packaging and sterilization of ILUVIEN.
Upon approval of ILUVIEN, pSivida would be entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits, as defined, on sales of the drug by Alimera.
“We look forward to the FDA’s response to Alimera’s resubmission of the NDA for ILUVIEN for DME, which if approved, would be our third FDA-approved product,” said Dr. Paul Ashton, President and Chief Executive Officer of pSivida. “We are also working on several earlier stage technologies including bioerodible systems to deliver proteins and small drug molecules for macular degeneration and glaucoma.”
Alimera also reported that it believes the deficiencies in current good manufacturing practices (cGMP) observed during facility inspections at two of Alimera’s third-party manufacturers of ILUVIEN noted by the FDA in the CRL had been resolved and that no further action is required because the FDA issued letters to both of these third-party manufacturers indicating that the inspections were now closed.
Date: May 13, 2011
Source: pSivida Corp.
Filed Under: Drug Discovery