Bausch + Lomb and Clearside Biomedical Announce U.S. FDA Filing Acceptance for XIPERE

Friday, June 4 2021 | 15 h 48 min | News

Bausch + Lomb, along with Clearside Biomedical, a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, 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.

According to the company, Bausch + Lomb has the exclusive license for the commercialization and development of XIPERE in the United States and Canada.

“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.

“XIPERE has the potential to advance the care of people suffering from macular edema with uveitis,” said George Lasezkay, Pharm.D., J.D., 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®).”

XIPERE is designed for suprachoroidal administration via Clearside’s patented, proprietary SCS Microinjector® that offers unprecedented access to the back of the eye where sight-threatening disease often occurs.

Click HERE for the full press release.