FDA Approves Drug That Treats Vision Loss from Inflammation
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Bausch Health Companies and Clearside Biomedical announced Monday that the US Food and Drug Administration has approved "Xipere" for the treatment of macular edema associated with uveitis.
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The FDA approves "Xipere" to treat vision loss resulting from an inflammatory eye condition.
According to Reuters, Bausch Health Companies Inc and Clearside Biomedical Inc said on Monday that the US Department of Health and Human Services approved Xipere, an eye injection that allows patients to try a new treatment for vision loss resulting from an inflammatory eye condition.
The drug is injected into the back of the eye; it carries a version of a steroid usually used to treat uveitis, an inflammation of tissues in the eye.
Macular edema, a build-up of fluid in a part of the retina, is the main cause of vision loss among people with uveitis.
Clearside's late-stage study resulted in nearly half the patients on the treatment showing improvement in their vision.
The approval makes Xipere the first treatment using suprachoroidal to treat macular edema associated with uveitis, according to Joseph C. Papa, chairman and CEO of Bausch Health.
Bausch acquired the rights to develop and sell Xipere in the United States and Canada In 2019. The company expects to make the drug available in the United States during the first quarter of 2022.
