Clearside Biomedical, Inc. (NASDAQ:CLSD) Files An 8-K Other Events
Item 8.01Other Events.
On February 20, 2019, Clearside Biomedical, Inc. (the “Company”) announced that it had received notification from the U.S. Food and Drug Administration (the “FDA”) that the FDA had accepted for review the New Drug Application for the Company’s product candidate, XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis.The Prescription Drug User Fee Act (PDUFA) goal date has been assigned for October 19, 2019.
About Clearside Biomedical, Inc. (NASDAQ:CLSD)
Clearside Biomedical, Inc. is a clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye. The Company’s product candidates focus on diseases affecting the retina, which is the tissue that lines the inside of the eye and is primarily responsible for vision, and the choroid, which is the layer adjacent to the retina that supplies the retina with blood, oxygen and nourishment. With its microinjector, drugs are injected into and spread within and through the suprachoroidal space, (SCS), which is the space located between the choroid and the outer protective layer of the eye known as the sclera. With the suprachoroidal injection, its product candidates are more directly administered to the retina and choroid as compared to other ocular drug administration techniques, such as injections of drug into the vitreous, a jelly-like substance that occupies the central portion of the eye.