Nov 4, 2021

FDA approves Bausch + Lomb and Clearside’s XIPERE for macular edema

FDA Approved

by: Alex Delaney-Gesing

The FDA has approved XIPERE for the treatment of macular edema associated with uveitis

The FDA approved XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use. It will be used to treat macular edema associated with uveitis.

The approval makes XIPERE the first — and currently only — therapy utilizing suprachoroidal to treat macular edema associated with uveitis, according to Joseph C. Papa, chairman, and CEO of Bausch Health, in a company news release.

XIPERE is designed to provide treatment via the suprachoroidal administration with the proprietary SCS Microinjector developed by Clearside Biomedical, the news release stated.

Three clinical programs investigated XIPERE: PEACHTREE, a randomized, multi-center, double-masked, sham-controlled phase clinical trial; MAGNOLIA, a multi-center, non-interventional extension study; and AZALEA, an open-label safety trial.

FDA approval was based on results from the PEACHTREE trial, which included 160 patients diagnosed with macular edema associated with uveitis. XIPERE is also the first — and only — treatment for uveitic macular edema to demonstrate clinical efficacy with a best-corrected visual acuity (BCVA) primary endpoint, according to the release……

Read more: https://www.optometrytimes.com/view/fda-approves-bausch-lomb-and-clearside-s-xipere-for-macular-edema?utm_source=sfmc&utm_medium=email&utm_campaign=11032021_OD_NOT-21-OTD0248_XCE-21-OTD0251_eNL_Notal%20Vision%20Viewpoint_x-Cel%20Specialty%20Contacts&eKey=ZG9ubmFAbWFjdWxhcmhvcGUub3Jn

Source: Optometry Times

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