pSivida announces resubmission of New Drug Application for ILUVIEN®

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today 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.

“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”

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.

About the FAME Study

The FAME study, conducted by Alimera, consisted of two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME) study for ILUVIEN involving 956 patients in site across the United States, Canada, Europe and India to access the efficacy and safety of ILUVIEN with two doses of the corticosteroid fluocinolone acetonide (FAc), a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference between the treatment and control groups. The study concluded in October 2010 with the final patient visit at the three-year data point.

About DME

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.

About ILUVIEN®

ILUVIEN is an investigational, extended release intravitreal insert for the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc. ILUVIEN is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.