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

ME Staff 8-k
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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 November 30,
2016, 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 24 months into its 3-year pivotal study and
anticipates submitting data to the FDA in September 2017. To
date, 50% of the subjects have passed through the 12 month
post-operative visit. Data (representing 50% of the study cohort
and excluding subjects who explanted the Microlens or did not
return for scheduled trial visits and considered lost to
follow-up) made available to the Company indicates that:

Subjects gained an average of 5 lines of uncorrected near
visual acuity (the ability to see close objects without
prescription enhancement) in treated eyes (Figure A),

Approximately 83% of subjects achieved 20/40 or better
uncorrected distance vision in treated eyes (Figure B)
and there was little to no change in binocular
uncorrected distance vision (Figure C), and

Approximately 98% of subjects achieved 20/40 or better
best corrected distance vision in the treated eyes
(Figure D) and there was little to no change in binocular
best corrected distance vision (Figure E). (Presbia
Flexivue Microlens is designed to take advantage of
binocular vision as most patients fuse both images in the
brain. The brain filters bad images, thus, resulting in
accepting the best images. This process is known as
neuroadaptation.).

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 treated 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 treated 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, 2015.

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


About PRESBIA PLC (NASDAQ:LENS)



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