Current Report Filing (8-k)

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): September 10, 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:

o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o	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 September 10, 2015, Presbia PLC (the “Company”) announced the completion of the second stage enrollment of its U.S. Food and Drug Administration pivotal clinical trial for its microlens. A copy of the Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Number		Exhibit

99.1		Press Release, dated September 10, 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: September 14, 2015

Exhibit Index

Number		Exhibit

99.1		Press Release of Presbia PLC, dated September 10, 2015.

Exhibit 99.1

Sep 10, 2015

Previous Release

PDF

Presbia Completes Second Stage Enrollment in the US FDA Pivotal Study of Presbia Flexivue Microlens™

DUBLIN--(BUSINESS WIRE)-- Presbia PLC (NASDAQ: LENS), an ophthalmic device company and leader in near vision restoration announced that it has completed the second stage enrollment of its U.S. Food and Drug Administration (FDA) pivotal study, a significant milestone in the FDA approval process of its Presbia Flexivue Microlens™.

In February, Presbia received FDA approval to commence the second stage pivotal study of its Microlens, which required enrollment of 337 qualified subjects. As the study ramped-up, the majority of the patients were enrolled in less than five months, meeting Presbia's target to complete the required enrollment by the end of the third quarter.

"Completing the second stage enrollment of our pivotal study is an important milestone in advancing our goal of obtaining FDA approval," said Todd Cooper, President and CEO of Presbia. "Securing FDA approval will allow us to provide the Presbia Flexivue Microlens to U.S. consumers as a safe and effective treatment option for presbyopia."

The many surgeons who participated in the study were equally impressed with the rapid enrollment. "Presbia's professionalism in handling the study enrollment as well as its well-documented procedures made this a process that ran seamlessly," commented Dr. Robert Maloney, Presbia's primary medical monitor and investigator participating in the Presbia study, and a surgeon at Maloney Vision Institute, Los Angeles, CA.

The Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision, has been commercially available in the European Union and other countries around the world where it has obtained regulatory approvals.

Forward-Looking Statements

Information provided and statements contained in this press release that are not purely historical are forward-looking statements. Such forward-looking statements only speak as of the date of this press release and Presbia assumes no obligation to update the information included in this press release. Statements made in this press release that are forward-looking in nature may involve risks and uncertainties. Accordingly, readers are cautioned that any such forward-looking statements are not guarantees and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Although Presbia believes that the

expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Unless otherwise required by law, Presbia also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made in this press release.

About Presbia

Presbia PLC (NASDAQ:LENS) is an ophthalmic device company that has developed and is currently marketing the presbyopia-correcting Presbia Flexivue Microlens™, a miniature lens that is implanted in a corneal pocket created by a femtosecond laser. The Presbia Flexivue Microlens™ has received a CE mark for the European Economic Area, allowing the lens to be marketed in over 30 countries across Europe. A staged pivotal U.S. clinical trial for the Presbia Flexivue Microlens™ commenced in 2014.

View source version on businesswire.com: http://www.businesswire.com/news/home/20150910005629/en/