Bausch Health, Clearside Get FDA Approval for Xipere
25 Octubre 2021 - 6:28AM
Noticias Dow Jones
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
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