pSivida's licensee submits NDA to FDA for Iluvien

Jul 1 2010

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences (NASDAQ:ALIM) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Iluvien® for Diabetic Macular Edema. Iluvien, developed by pSivida and licensed to Alimera Sciences in 2005, is a sustained release drug delivery system releasing the steroid flucocinolone acetonide for the treatment of diabetic macular edema (DME). In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of this year.

“There are currently no drugs approved to treat DME, one of the leading causes of vision loss. Iluvien's clinical trials have demonstrated that Iluvien can significantly improve vision in DME patients.”

Dr. Paul Ashton, President and CEO of pSivida, said, "There are currently no drugs approved to treat DME, one of the leading causes of vision loss. Iluvien's clinical trials have demonstrated that Iluvien can significantly improve vision in DME patients." Dr. Ashton continued, "This is our third product for back-of-the-eye diseases to be submitted to the FDA for approval. The first two were approved, are currently on the market and are two of the only three sustained release drug delivery systems currently approved by the FDA to treat back-of-the-eye conditions."

Two pivotal phase three clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients in sites across the United States, Canada, Europe and India are being completed to assess the efficacy and safety of Iluvien for the treatment of DME. The primary efficacy endpoint for the FAME Study is the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study will conclude later this year with the final patient visits at the three-year data point. The 24-month clinical read out from the study was announced in December 2009.

The NDA submission includes the 24-month low dose data from the FAME Study. Alimera has indicated that it plans to follow this NDA submission with registration filings in certain European countries and Canada in the near future. pSivida has joint ownership and reference rights to this NDA.

pSivida continues to work to develop new products for the sustained release of drugs and proteins based on its existing and new technologies. Additionally, Pfizer and pSivida are collaborating to develop ophthalmic products based on pSivida technology. While the Company remains primarily focused in ophthalmology, pSivida is exploring other therapeutic areas.