Clearside receives notification of FDA acceptance of NDA filing for Xipere
Clearside Biomedical announced that it received notification from the U.S. Food and Drug Administration that the Agency has accepted for review the New Drug Application for XIPERE for Suprachoroidal Injection for the treatment of macular edema associated with uveitis. The FDA has determined that the application is sufficiently complete to permit a substantive review. The PDUFA goal date has been assigned for October 19, 2019. This date reflects a standard review period and is consistent with management's expectations for the 505(b)(2) filing. The NDA filing is supported by data from the Phase 3, PEACHTREE clinical trial that demonstrated significant and clinically meaningful improvement in vision for patients with macular edema associated with non-infectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. Also, in patients with active inflammation at baseline, resolution was achieved in more than two-thirds of those treated with XIPERE across three commonly used measures of inflammation: vitreous haze, anterior chamber cells and anterior chamber flare.