BRIDGEWATER, N.J. and ALPHARETTA, Ga.—Bausch + Lomb and Clearside Biomedical announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension). FDA determined that the filing is a Class 2 resubmission and therefore assigned a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021. XIPERE is an investigational therapy with a proposed indication of treatment of macular edema associated with uveitis. “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,” said Yolande Barnard, vice president and general manager, U.S. pharmaceuticals, Bausch + Lomb. “This filing acceptance is an important milestone for Bausch + Lomb and Clearside as it brings us closer to our goal of bringing this novel treatment option to patients with this condition.”

“XIPERE has the potential to advance the care of people suffering from macular edema with uveitis,” said George Lasezkay, PharmD., JD, president and CEO, Clearside. “If approved, XIPERE would be our first commercial product and the first approved drug to be delivered into the suprachoroidal space (SCS). We are committed to continuing the important work with Bausch Health to help bring forward this important potential treatment option for patients and eyecare professionals in the United States.”