DUBLIN--(BUSINESS WIRE)--Presbia PLC (NASDAQ: LENS), an ophthalmic device company and leader in near-vision restoration, announced that all 421 subjects treated with the Presbia Flexivue Microlens™ as part of its U.S. Food and Drug Administration (FDA) pivotal study completed their 6-month post-operative visits, one step closer to making the submission of its final PMA module to the FDA in approximately 18 months. The Presbia Flexivue Microlens is a revolutionary optical lens implant for treating presbyopia, the age-related loss of near-vision.
Once 300 of the 421 subjects complete their 24-month post-operative visits and after the related data has been compiled, Presbia will submit its final PMA module to the FDA, which is anticipated in Q4 2017.
"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.
Presbia is concurrently pursuing a focused approach to its commercial strategy outside of the U.S. with activities taking place in South Korea, followed by Germany, which will demonstrate the superiority, safety, and efficacy of Presbia’s Microlens technology.
Additional information related to the subjects’ 6-month post-operative visits is provided in Presbia’s Form 8-K filing.
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.