LAVAL, QC and ALPHARETTA, Ga.—Bausch + Lomb, a global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) and Clearside Biomedical, Inc. (Nasdaq: CLSD) announced Monday that the U.S. Food and Drug Administration (FDA) has approved the drug Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. "With this FDA approval, Xipere is the first and only therapy available in the United States that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis," said Joseph C. Papa, chairman and CEO, Bausch Health.

"The utilization of the suprachoroidal space provides targeted delivery and compartmentalization of medication. The approval of Xipere exemplifies our commitment to bringing innovative new options to help patients improve their treatment journey. We expect to make Xipere available during the first quarter of 2022," he said.
George Lasezkay, Pharm.D., J.D., president and CEO, Clearside, commented, "The suprachoroidal space is an untapped frontier in eye health. We are proud to be the pioneers in treating serious retinal diseases by implementing this novel, targeted approach.
"With this approval, we begin a new era in delivering therapies to the back of the eye. Xipere is the first commercial product developed by Clearside, the first product approved for injection into the suprachoroidal space and the first therapy approved for macular edema associated with uveitis. Our unique approach now has the potential to positively impact this patient population, which previously had no other treatment options approved for this indication."
Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss. Xipere is designed to treat macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector developed by Clearside. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid.
"The safety and efficacy data of Xipere was demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye," said Steven Yeh, M.D., professor of ophthalmology and director of retinal disease and uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, and principal investigator for the Xipere Phase 3 (PEACHTREE) pivotal study. "With the approval of Xipere, eyecare professionals now have a new and innovative treatment option for their patients with macular edema associated with uveitis," Yeh said.