Bausch Health and Clearside Biomedical announce FDA re-filing acceptance for Xipere to treat macular edema associated with uveitis.

FDA determined that the filing is a Class 2 resubmission and therefore assigned a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021. Xipere is an investigational therapy with a proposed indication of treatment of macular edema associated with uveitis. Xipere is designed for suprachoroidal administration via Clearside's patented, proprietary SCS Microinjector that offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication. Targeted drug delivery via the suprachoroidal space may also limit corticosteroid exposure to the anterior segment with the potential to reduce the risk of certain adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that can commonly arise from other local corticosteroid delivery techniques..