pSivida Resubmits Application For Eye Disease Drug Iluvien

pSivida announced that the company is resubmitting an FDA drug application for their eye disease drug, Iluvien. The drug treats diabetic macular edema, which can lead to blindness. The disease affects about one million people living in the U.S. The Iluvien drug is injected into the back of a patient’s eye, and working through the patient’s natural fluid dynamics. The applicator’s 25-gauge needle creates a self-sealing wound.

According to the PSivida company press release, the company’s licensee, Alimera Sciences, has responded to questions from the FDA raised in the previous drug application process for Iluvien. Alimera also provided a safety update on the drug. The previous submission took place in October of 2013. The resubmission contained information from the drug’s commercial experience in Europe. The company is now awaiting the FDA’s acceptance of their new drug application.

Dan Myers, Alimera’s president and chief executive officer, also commented on the reapplication process. “We are pleased to resubmit ILUVIEN for approval in the United States,” said Myers. “We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed."

"We are pleased with the resubmission of the NDA for ILUVIEN, which brings us one step closer to potential approval in the United States," said Paul Ashton, pSivida's president and CEO.

pSivida specializes in treating eye diseases, and it has manufactured products that deliver drugs at a controlled rate. PSivida has already received marketing authorization for Iluvien in Spain, Portugal, Germany, France, Austria, and the UK.