SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 02, 2021
Clearside Biomedical, Inc.
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction
(Commission File Number)
900 North Point Parkway
(Address of Principal Executive Offices)
Registrant’s Telephone Number, Including Area Code: 678 270-3631
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, par value $0.001 per share
The NASDAQ Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 8.01 Other Events.
On June 2, 2021, Clearside Biomedical, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Company’s resubmitted New Drug Application for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis. FDA determined that the filing is a Class 2 resubmission and therefore assigned a Prescription Drug User Fee Act action date of October 30, 2021.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: June 4, 2021
CLEARSIDE BIOMEDICAL, INC.
/s/ Charles A. Deignan
Charles A. Deignan
Chief Financial Officer