By Chris Wack

 

Bausch Health Cos. unit Bausch + Lomb and Clearside Biomedical Inc. said the U.S. Food and Drug Administration has approved Xipere triamcinolone acetonide injectable suspension for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.

Bausch Health said it expects Xipere to be available during the first quarter of 2022.

Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss. Xipere is designed to treat macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector developed by Clearside, Bausch said.

The FDA approval of Xipere was based on results from a trial of 160 patients with macular edema associated with uveitis, designed to demonstrate clinical efficacy with a Best Corrected Visual Acuity primary endpoint.

The primary efficacy endpoint was the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up. In the trial, a statistically significantly greater proportion of patients treated with Xipere achieved at least a 15-letter improvement in BCVA than patients in the control arm at week 24.

The most common adverse reactions reported by greater than or equal to 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain.

Clearside shares were up 9% to $6.19 in premarket trading. Bausch Health shares were up 2% to $29.10 in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

October 25, 2021 07:13 ET (11:13 GMT)

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