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.
Forward-Looking Statements
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.
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.
