Bausch + Lomb announced today that the journal Ophthalmology has published results from the PEACHTREE Phase 3 clinical trial of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), an investigational treatment with a proposed indication of macular edema associated with uveitis.
XIPERE, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye. Suprachoroidal injection enables the rapid and adequate dispersion of the drug for the potential to act longer and minimize harm to the surrounding healthy parts of the eye.
Safety and efficacy of XIPERE was evaluated in the PEACHTREE study, a randomized, controlled, masked, Phase 3 clinical trial. 160 patients with macular edema associated with noninfectious uveitis were recruited to receive XIPERE at baseline and at 12 weeks versus control.
PEACHTREE results showed that patients that received XIPERE improved experienced clinically significant improvement in vision. The study met its primary endpoint, with 47 percent of patients in the XIPERE arm gained at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16 percent of patients in the control. No serious adverse events (AEs) considered by the investigators related to treatment were reported.
“The efficacy and safety data from the PEACHTREE Phase 3 trial showed that delivery of XIPERE via suprachoroidal administration, an alternative technique for delivering ocular therapies, may facilitate more targeted delivery of therapeutic agents to the retina and choroid,” said Steven Yeh, M.D., lead author and principal investigator for the PEACHTREE study.
“Targeted drug delivery via the suprachoroidal space may also limit corticosteroid exposure to the anterior segment with the potential to decrease adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma that can commonly arise from other local corticosteroid delivery techniques.”
An affiliate of Bausch Health acquired the exclusive license for the commercialization and development of XIPERE in the United States and Canada in October 2019.
“We are coordinating closely with Bausch Health, our exclusive licensee of XIPERE in the United States and Canada, and are excited for the potential to add this treatment option to the repertoire for retinal specialists,” said Thomas A. Ciulla, M.D., MBA, chief medical officer, Clearside Medical.
Full news release: https://www.bausch.com/our-company/recent-news/artmid/11336/articleid/640/01282020-tuesday