XIPERE, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Corticosteroids are the standard of care in uveitis and are effective at treating the inflammatory aspect of ocular disease.
Uveitis is a set of ocular inflammatory conditions affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of uveitis patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. Macular edema is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location—anterior, intermediate, posterior or panuveitis.
XIPERE met its primary endpoint in a pivotal, Phase 3 clinical trial known as PEACHTREE. It also demonstrated durability in the MAGNOLIA Phase 3 extension study.
If approved, XIPERE would be the first therapy for macular edema associated with uveitis.