FDA Approves Targeted Therapy for Macular Edema

Xipere is delivered via an injection to the back of the eye to treat macular edema associated with uveitis, a form of eye inflammation.

The FDA has approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. Developed by Bausch + Lomb, and Clearside Biomedical, Xipere provides a targeted delivery to the retina and choroid.

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.

The FDA approval was based on results from PEACHTREE, a phase 3 clinical trial of 160 patients with macular edema associated with uveitis. The primary efficacy end point was the proportion of patients in whom BCVA (Best Corrected Visual Acuity) had improved by at least 15 letters from baseline after 24 weeks of follow-up. In the trial, 47% of patients achieved at least a 15-letter improvement in BCVA compared with 16% of patients in the control arm.

The most common adverse reactions reported by greater than or equal to 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain.

“The safety and efficacy data of Xipere were demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye,” 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 in PEACHTREE study, said in a statement.