Ophthalmology publishes Bausch, Clearside pivotal XIPERE data

Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, published results of a Phase 3 clinical trial by Bausch Health Companies (NYSE, TSX:BHC) and Clearside Biomedical (NASDAQ:CLSD) of XIPERE for the treatment of macular edema associated with uveitis.

“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,” Dr. Steven Yeh, lead author and principal investigator for the PEACHTREE study, and M. Louise Simpson associate professor of ophthalmology, Emory Eye Center.

“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,” he added.

The data demonstrated that patients with non-infectious uveitis in the XIPERE study arm experienced clinically significant improvement in vision relative to the control arm, demonstrating the potential efficacy of suprachoroidal injection of XIPERE for the treatment of macular edema associated with uveitis. No serious adverse events considered by the investigators related to treatment were reported.

Dr. Thomas Ciulla, CMO of Clearside, said, “We are coordinating closely with Bausch Health, our exclusive licensee of XIPERE in the U.S. and Canada, and are excited for the potential to add this treatment option to the repertoire for retinal specialists.” 


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