Bausch, Clearside receive U.S. approval for eye injection

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland
·1 min read

(Reuters) - Bausch Health Companies Inc and Clearside Biomedical Inc said on Monday they received approval from the U.S. health regulator for their eye injection, giving patients access to a novel treatment for vision loss resulting from an inflammatory eye condition.

The drug, Xipere, is injected to the back of the eye and delivers a version of a steroid commonly used for the treatment of uveitis, an inflammation of tissues in the eye.

Macular edema, a build-up of fluid in a part of the retina, is the leading cause of vision loss among people with uveitis.

Xipere achieved its main goal in Clearside's late-stage study, with nearly half the patients on the treatment showing improvement in the clarity of their vision. The drug was also shown to be generally well tolerated.

With Xipere, high levels of medication can be delivered to target tissues, such as the retina and the drug can treat the swelling, leading to visual improvement, Dr. Steven Yeh, the main investigator for the study, told Reuters in an interview.

The drug delivery approach is the first of its kind for the treatment of macular edema stemming from noninfectious uveitis, which affects about 300,000 adults in the United States, Dr. Yeh said.

Other drugs used to treat the condition in the United States include Bristol Myers Squibb's Kenalog, administered near the eye and AbbVie Inc's Ozurdex eye implant. There are some topical treatments as well.

In 2019, Bausch acquired the rights to develop and sell Xipere in the United States and Canada from Clearside.

Bausch expects to make Xipere available in the United States during the first quarter of 2022.

(Reporting by Amruta Khandekar; Editing by Maju Samuel)

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