The Food and Drug Administration (FDA) has approved Xipere™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis.
The approval was based on data from the multicenter, randomized, double-masked, sham-controlled phase 3 PEACHTREE trial (ClinicalTrials.gov Identifier: NCT02595398), which evaluated the efficacy and safety of Xipere in 160 patients with macular edema associated with anterior-, intermediate-, posterior-, or pan-uveitis. Patients were randomly assigned to receive either Xipere (n=96) or sham (n=64) via suprachoroidal injection at 2 time points.
Results showed that a statistically significantly greater proportion of patients treated with Xipere met the primary endpoint achieving at least a 15-letter improvement in Best Corrected Visual Activity at 24 weeks from baseline compared with those treated with sham (47% vs 16%, respectively; estimated difference 31% [95% CI, 15-46]; P <.01). The most common adverse reactions reported were elevated intraocular pressure and eye pain.
The approval of Xipere was also supported by data from the multicenter, noninterventional extension MAGNOLIA study (ClinicalTrials.gov Identifier: NCT02952001) and the open-label safety AZALEA trial (ClinicalTrials.gov Identifier: NCT03097315).
“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.”
Xipere is administered via suprachoroidal injection using the SCS Microinjector®, which is supplied with a single-dose vial of triamcinolone acetonide injectable suspension 40mg/mL. The product is expected to be available in the first quarter of 2022.
- Bausch + Lomb and Clearside Biomedical announce FDA approval of Xipere™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. News release. Bausch Health Companies Inc. and Clearside Biomedical, Inc. Accessed October 25, 2021. https://www.prnewswire.com/news-releases/bausch–lomb-and-clearside-biomedical-announce-fda-approval-of-xipere-triamcinolone-acetonide-injectable-suspension-for-suprachoroidal-use-for-the-treatment-of-macular-edema-associated-with-uveitis-301407260.html.
- Xipere. Package insert. Clearside Biomedical, Inc.; 2021. Accessed October 25, 2021. https://www.bauschhealth.com/Portals/25/Pdf/PI/XIPERE-PI.pdf.