Source:

Press Release

October 25, 2021
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FDA approves Xipere to treat macular edema associated with uveitis

Source:

Press Release

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The FDA has approved Xipere for suprachoroidal use in the treatment of macular edema associated with uveitis, according to a press release from Bausch + Lomb and Clearside Biomedical.

Xipere (triamcinolone acetonide injectable suspension) is the first approved treatment to use the suprachoroidal space as a delivery pathway for the treatment of macular edema associated with uveitis, the release said.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock

“The utilization of the suprachoroidal space provides targeted delivery and compartmentalization of medication,” Joseph C. Papa, chairman and CEO of Bausch Health, said in the release. “The approval of Xipere exemplifies our commitment to bringing innovative new options to help patients improve their treatment journey.”

The approval was based on the results of the randomized, multicenter, double-masked, sham-controlled phase 3 PEACHTREE trial, which included 160 patients with macular edema due to uveitis. In the trial, 47% of patients treated with Xipere achieved an improvement in best corrected visual acuity of at least 15 letters from baseline at 24 weeks compared with 16% of patients in the control arm (P < .01).

Xipere is expected to be available in the first quarter of 2022.