Clearside Biomedical, Inc. (Nasdaq: CLSD), 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 the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis.
Clearside’s resubmission is a full and complete response to all of the items identified in the Complete Response Letter (CRL) received from the FDA on October 18, 2019. Clearside believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act.
“The resubmission of the XIPERE NDA is an important milestone for Clearside,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside Biomedical. “As the pioneers in treating back of the eye diseases through the suprachoroidal space, we believe our extensive clinical experience with XIPERE shows the potential for a reliable, non-surgical, office-based method for the treatment of a broad range of retinal diseases. We appreciate the continued support and input from our global commercialization partners, Bausch + Lomb and Arctic Vision, as we look towards the opportunity to improve the lives of patients suffering from macular edema associated with uveitis.”
About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)
XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis.
Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and an exclusive option for commercialization and development of XIPERE in Europe and the United Kingdom, Australia and New Zealand, and/or South America and Mexico. Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea. XIPERE is not yet approved in any jurisdiction.