pSivida Corp. 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 been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).
FDA Priority Review status is given to therapies that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This status reduces the review time goal from 10 months to six months.
Dr. Paul Ashton, President and CEO of pSivida said, “With priority review a response from the FDA regarding Iluvien could be received in the fourth quarter of this year. Approval of Iluvien would trigger a $25 million milestone payment to pSivida from Alimera. Under the license agreement pSivida is also to receive 20 percent of net profits on sales by Alimera.”
The news regarding priority review follows the submission last month of the Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain. Filing in Canada is expected to take place in September. pSivida has joint ownership and reference rights to these regulatory filings.
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.
SOURCE pSivida Corp.