Xipere® (triamcinolone acetonide injectable suspension) is now available for suprachoroidal use for the treatment of macular edema associated with uveitis.
The approval of Xipere was based on data from the phase 3 PEACHTREE trial (ClinicalTrials.gov Identifier: NCT02595398), which included 160 patients with macular edema associated with anterior-, intermediate-, posterior-, or pan-uveitis. Findings from the trial 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.
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).
As for safety, the most common adverse reactions for Xipere, reported by at least 10% of patients and at a rate greater than control, included elevated intraocular pressure and eye pain. Xipere is contraindicated for use in patients with ocular or periocular infections.
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 commercialization of Xipere® is an exciting step forward for the treatment of macular edema associated with uveitis, and also for increasing education and recognition of the suprachroidal space as a highly effective administration route for back-of-the-eye therapies,” said George Lasezkay, PharmD, JD, president and CEO, Clearside. “As the first commercial product developed by Clearside and the first therapy approved for macular edema associated with uveitis, Xipere® represents our commitment to delivering much needed treatments for those living with serious retinal diseases.”
Bausch + Lomb and Clearside Biomedical announce the US commercial launch of Xipere® (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. News release. Bausch Health Companies Inc. Accessed March 28, 2022. https://www.prnewswire.com/news-releases/bausch–lomb-and-clearside-biomedical-announce-the-us-commercial-launch-of-xipere-triamcinolone-acetonide-injectable-suspension-for-suprachoroidal-use-for-the-treatment-of-macular-edema-associated-with-uveitis-301511357.html