Clearside Biomedical, Inc. (NASDAQ:CLSD) Files An 8-K Other Events
Item 8.01 Other Events.
Clearside Biomedical, Inc. (the “Company”) was recently informed by its commercial contract manufacturer for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), that the U.S. Food and Drug Administration has requested that the manufacturer complete certain manufacturing activities within its facility. These activities are not specifically related to XIPERE, but Clearside expects a delay in the production of the drug product stability data needed to resubmit its New Drug Application (“NDA”). Based on current information from the manufacturer, the Company now expects to resubmit the XIPERE NDA in the second quarter of 2020.
On November 20, 2019, members of management of the Company will present at the Stifel 2019 Healthcare Conference on, among other things, the Company’s product candidate pipeline and clinical and regulatory status. A copy of the presentation that is being presented at the conference is available on the Company’s website at www.clearsidebio.com, and is filed as Exhibit 99.1 to this Current Report on Form 8-K, the contents of which are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Clearside Biomedical, Inc. Exhibit
EX-99.1 2 clsd-ex991_179.htm EX-99.1 clsd-ex991_179.pptx.htm Corporate Presentation | November 2019 Exhibit 99.1 Forward-Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995,…
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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.