UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 6, 2015
PRESBIA PLC
(Exact Name of Registrant as Specified in Charter)
| Ireland | 001-36824 | 98-1162329 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
120/121 Baggot Street Lower
Dublin 2 Ireland
(Address of Principal Executive Offices)(Zip Code)
+353 (1) 659 9446
Registrant’s Telephone Number
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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01. | Other Events |
On February 6, 2015, Presbia PLC (the “Company”) issued a press release announcing that it received approval from the United States Food and Drug Administration (FDA) to commence second stage enrollment in the Company’s staged pivotal clinical trial of the Presbia Flexivue Microlens™. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit | Description | |
| 99.1 | Press Release of Presbia PLC dated February 6, 2015. | |
SIGNATURES
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 hereunto duly authorized.
| PRESBIA PLC | ||
| By: | /s/ Richard Fogarty | |
| Name: | Richard Fogarty | |
| Title: | Chief Accounting Officer | |
Dated: February 9, 2015
