Clearside Biomedical Inc. submitted a new drug application with the U.S. Food and Drug Administration seeking approval for its eye drug Xipere.
The Alpharetta, Ga.-based drugmaker is seeking the regulator's nod for Xipere as a treatment for macular edema — a build-up of fluid in a part of the eye — associated with uveitis, or the inflammation of the eye's middle layer.
Uveitis affects about 350,000 patients in the U.S. and over a million globally, Clearside said in a news release.