The FDA has approved Xipere triamcinolone acetonide suprachoroidal injectable suspension (Bausch Health and Clearside Biomedical) for the treatment of macular edema associated with uveitis. Xipere is the first and only therapy approved in the United States that uses the suprachoroidal space for drug delivery.

Xipere is delivered via suprachoroidal administration using the patented, proprietary SCS Microinjector developed by Clearside Biomedical. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid. It is designed to provide targeted and compartmentalized delivery and higher proportions of absorption relative to intravitreal injection. Targeted drug delivery via the suprachoroidal space may also limit corticosteroid exposure to the anterior segment with the potential to reduce the risk of certain adverse events, such as cataracts, intraocular pressure elevation, and exacerbation of glaucoma, that are commonly associated with local delivery techniques, according to the companies.

“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, MD, 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, in a news release.

The clinical program for Xipere included PEACHTREE, MAGNOLIA (a phase 3, multicenter, noninterventional extension study), and AZALEA (an open-label safety trial). The FDA approval was based on results from PEACHTREE, a randomized, multicenter, double-masked, sham-controlled phase 3 clinical trial of 160 patients with macular edema associated with uveitis. Xipere is the first and only uveitic macular edema treatment to demonstrate clinical efficacy with a best-corrected visual acuity primary (BCVA) endpoint.

The primary efficacy endpoint was the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up. In the trial, a statistically significantly greater proportion of patients treated with Xipere (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, P<.01) at week 247. 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.