Benzinga | Jun 2, 2021 07:00AM EDT

Bausch Health And Clearside Biomedical Announce U.S. FDA Filing Acceptance For XIPERE

Bausch Health Companies Inc. (TSX:BHC) ("Bausch Health") and Bausch + Lomb, its leading global eye health business, along with Clearside Biomedical, Inc. (NASDAQ:CLSD) ("Clearside"), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application for XIPERE(tm)1 (triamcinolone acetonide suprachoroidal injectable suspension). 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.

"The FDA's filing acceptance for XIPERE is an exciting milestone for our collaboration with Clearside. If approved by the FDA, XIPERE would be the first therapy available utilizing the suprachoroidal space for patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis. With this acceptance, we are one step closer to providing an important novel treatment option for this patient population," said Joseph C. Papa, chairman and CEO, Bausch Health.

"XIPERE has the potential to advance the care of people suffering from macular edema with uveitis," said George Lasezkay, Pharm.D., J.D., president and CEO, Clearside. "If approved, XIPERE would be our first commercial product and the first approved drug to be delivered into the suprachoroidal space (SCS(r)). We are committed to continuing the important work with Bausch Health to help bring forward this important potential treatment option for patients and eye care professionals in the United States."

XIPERE is designed for suprachoroidal administration via Clearside's patented, proprietary SCS Microinjector(r) 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.