PRESBIA PLC (NASDAQ:LENS) Files An 8-K Other Events

Item 8.01

Update on U.S. Staged Pivotal Clinical Trial

Presbia PLC (the Company) hereby reports certain interim data
from its U.S. staged pivotal clinical trial. Through May 19,
2017, 421 subjects have undergone insertion of the Companys
microlens during the staged pivotal clinic trial that the Company
is performing to obtain the clinical data required to enable the
Company to obtain pre-market approval from the FDA. Currently,
the Company is 27 months into its 3-year pivotal study and
anticipates submitting the PMA to FDA in the fourth quarter of
2017. To date, 50% of the subjects have passed through the 18
month post-operative visit. Data (representing 50% of the study
cohort and excluding subjects who had the Microlens explanted or
those that did not return for scheduled trial visits and
considered lost to follow-up) made available to the Company
indicates that:

The following chart summarizes the uncorrected near visual acuity
in the treated eyes:

Figure A

The following chart summarizes the uncorrected distance vision in
the operated eyes:

Figure B

The following chart summarizes the binocular uncorrected distance
visual acuity:

Figure C

The following chart summarizes the best corrected distance vision
in the operated eyes:

Figure D

The following chart summarizes the binocular best corrected
distance vision:

Figure E

Notwithstanding these results, we cannot assure you when or
whether the Company will obtain pre-market approval, or what
expenditures the Company will incur whether or not we obtain such
approval, given the many significant risks associated with
seeking such an approval from the FDA. Furthermore, certain
adverse events have been reported as part of the on-going staged
pivotal clinical trial. For a discussion of previously reported
adverse events please see the risk factors, including the risk
factor titled If concerns regarding side effects from presbyopia
correction surgery generally, or our products specifically,
develop, including as a result of third-party studies and
publications, our business, results of operations and financial
condition will be materially and adversely affected., in the
Companys annual report on Form 10-K for the year ended December
31, 2016.

The Company requires PMA approval in order to market its products
in the United States.

About PRESBIA PLC (NASDAQ:LENS)

Presbia PLC is an ophthalmic device company. The Company develops and markets an optical lens implant for treating presbyopia, the age-related loss of the ability to focus on near objects. The Company’s segment is the restoration of clear vision caused by presbyopia. The Company provides the refractive lens for patient surgeries and accessories for procedures performed exclusively outside the United States. The Company’s lens, referred to as the microlens, is a miniature lens designed to be surgically implanted in a patient’s eye to improve that patient’s ability to see objects at close distances. The microlens is a disc shaped lens that has a refractive zone in the periphery designed to improve near vision problems associated with presbyopia and a central zone that is designed to improve distance vision. The Company’s solution is a standalone solution for plano presbyopes, or those individuals suffering from presbyopia but do not have any other visual disorders.

PRESBIA PLC (NASDAQ:LENS) Recent Trading Information

PRESBIA PLC (NASDAQ:LENS) closed its last trading session up +0.03 at 2.72 with 4,301 shares trading hands.