Bausch’s and Clearside’s Eye Injection Secures FDA Approval

Bausch Health Cos. and Clearside Biomedical have won FDA approval for Xipere (triamcinolone acetonide), an injectable corticosteroid treatment for vision loss associated with uveitis, a type of eye inflammation.

The approval was supported by a 160-person phase 3 study, which showed that 47 percent of patients treated with Xipere saw a significant improvement in their Best Corrected Visual Acuity score at 24 weeks.

Xipere uses a novel delivery system to inject the corticosteroid to the back of the eye to address the buildup of fluid that causes causing retinal swelling and distorted vision. If left untreated, permanent vision loss may occur if the condition goes untreated.

The companies plan to launch Xipere in the U.S. early next year.