PSivida Corp. said Thursday that a new drug application for Iluvien, a treatment of diabetic macular edema, has been resubmitted to the US Food and Drug Administration.
Headquartered in Watertown, pSvida specializes in tiny drug delivery products for treating eye diseases. The products are designed to deliver drugs at a controlled and steady rate for long periods of time.
In the resubmission of the drug application, pSivida’s licensee, Alimera Sciences, responded to questions raised by the FDA in October, pSivida said in a press release.
According to pSvida’s website, Iluvien has already received marketing authorization in the UK, Austria, France, Germany, Portugal, and Spain.
Diabetic macular edema, or DME, is a potentially blinding condition that affects about one million people in the US.
The resubmission of the new drug application for Iluvien “brings us one step closer to potential approval in the United States,” Paul Ashton, pSivida’s president and chief executive, said in a statement.