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

by Mike Robinson

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© Reuters. FILE PHOTO – Signage outside the Food and Drug Administration headquarters in White Oak (Maryland, U.S.A), August 29, 2020. REUTERS/Andrew Kelly

(Reuters) – Clearside Biomedical and Bausch Health Companies (NYSE) Inc received Monday approval by the U.S. regulator for their new eye injection. Patients will now have access to a unique treatment for vision loss caused by an inflammatory eye condition.

Xipere is injected behind the eyes and contains a form of a steroid that can be used to treat uveitis (inflammation of tissue in the eye).

People with uveitis are most likely to experience vision loss from macular edema. This is caused by a buildup of fluid within a portion of their retina.

Clearside’s last-stage study showed that Xipere met its principal goal, and nearly half of patients receiving the drug saw improvements in their vision. Also, the drug was well-tolerated.

Xipere can deliver high amounts of medication to targeted tissues such as the retina. The drug can also treat swelling leading to visual improvements, said Dr. Steven Yeh (main investigator in the study), speaking to Reuters.

Dr. Yeh stated that the drug delivery method is unique in treating macular edema caused by noninfectious, uveitis. It affects approximately 300,000.

Another drug used in treating the condition in America is Bristol Myers’ (NYSE:). Squibb’s Kenalog, which is given near the eye. AbbVie Inc (NYSE:)’s Ozurdex eye implant. Some topical treatments are also available.

Bausch bought the rights to market and develop Xipere from Clearside in 2019,

Bausch hopes to have Xipere in the United States within the first quarter of 2022.

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