Health Canada has approved Clearside Biomedical’s Xipere, a triamcinolone acetonide injectable suspension administered with the company’s SCS Microinjector, for the treatment of macular edema associated with uveitis. The decision makes Canada the latest market to clear the suprachoroidal-space therapy after the United States, Australia and Singapore. Xipere is licensed to Bausch + Lomb for commercialization in the United States and Canada, while Beijing-based Arctic Vision holds rights in Greater China and several Asia-Pacific territories, where regulatory review is ongoing. The approval extends validation of Clearside’s proprietary suprachoroidal delivery platform, designed to target the back of the eye and limit off-target exposure. Investors welcomed the regulatory milestone, sending Clearside shares up roughly 77% in pre-market U.S. trading on Wednesday.
$CLSD +76% [Clearside's XIPERE (triamcinolone acetonide) for uveitic macular edema via SCS is now approved in the US, Canada, Australia, Singapore, and is under regulatory review in China. It utilizes the SCS Microinjector platform and is licensed to Bausch + Lomb and Arctic
$CLSD (+77.1% pre) Clearside Biomedical Announces Approval of XIPERE® Suprachoroidal Treatment for Uveitic Macular Edema in Canada https://t.co/ZBE27ptoQa
$CLSD - Clearside Biomedical Announces Approval of XIPERE® in Suprachoroidal Treatment for Uveitic Macular Edema in Canada - https://t.co/q4xNsqNOzp