FDA accepts NDA for Xipere
The FDA has accepted a resubmitted new drug application for Xipere for the treatment of macular edema associated with uveitis, according to a press release from Bausch + Lomb and Clearside Biomedical.
Xipere (triamcinolone acetonide suprachoroidal injectable suspension) is administered to the suprachoroidal space by way of Clearside’s SCS Microinjector, the release said.
“If approved by the FDA, Xipere would be the first therapy available utilizing the suprachoroidal space for patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis,” Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb, said in the release.
The prescription drug user fee act date has been set for Oct. 30.