Clearside Biomedical Inc. said the U.S. Food and Drug Administration rejected its application for eye inflammation treatment Xipere.
The company was seeking approval to market Xipere as a treatment for macular edema associated with uveitis, a condition characterized by the buildup of fluid in a part of the eye —leading to vision loss and blindness.
It is estimated that uveitis affects about 350,000 patients in the U.S. and over one million globally; about one-third of patients develop uveitic macular edema.
In its complete response letter, the regulator asked for additional stability data on the new manufacturing process for Xipere, an injectable form of a synthetic corticosteroid called triamcinolone acetonide. Alpharetta, Ga.-based Clearside said it would be able to address the request, plus another for additional data on the clinical use of the delivery system for the medicine, and resubmit its application in the first quarter of 2020.
The company also said the FDA did not identify any efficacy issues and made no requests for further clinical efficacy studies, but did ask to reinspect the drug's product manufacturer.