DUBLIN–(BUSINESS WIRE)–Presbia PLC (NASDAQ: LENS), an ophthalmic device company and leader in
near-vision restoration, announced today that all subjects treated as
part of the first stage of its U.S. Food and Drug Administration (FDA)
pivotal study completed their 12-month postoperative visits, a
significant milestone in the FDA approval process of its Presbia
Flexivue Microlens™. The Presbia Flexivue Microlens is a revolutionary
optical lens implant for treating presbyopia, the age-related loss of
near-vision. The Microlens has received regulatory approval and is
commercially available in more than 40 countries across Europe, Asia
Pacific, Latin America, the Middle East and Africa.
The FDA permitted Presbia to conduct its pivotal study in two stages.
The first stage had an enrollment of 75 subjects and the second stage an
additional 346 subjects. The second stage enrollment was completed in
early September 2015 and those participants will begin their 12-month
postoperative visits this month.
“We’ve had excellent follow-up of subjects participating in our study,
and our clinical investigators, their staff members as well as members
of our clinical department are continuing to keep track all subjects,”
said Todd Cooper, President and CEO of Presbia. “Once 300 subjects have
completed the 24-month postoperative visit and the related data has been
compiled, which is anticipated in Q4 2017, Presbia will submit its final
PMA module to the FDA.”
“Presbia continues to provide our clinic with any support we need,
making the follow-up of subjects that we’ve enrolled easier to track,”
commented Dr. Michael Gordon, a medical monitor and clinical
investigator for Presbia’s study, and ophthalmic surgeon at the Gordon
Schanzlin New Vision Institute in La Jolla, California.
This release contains “forward-looking statements” made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. 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,
including, but not limited to, the factors listed under “Risk Factors”
in our annual report on Form 10-K and quarterly reports on Form 10-Q.
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.
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.
Monica Yamada, 323-860-4903