Presbia Surpasses Treatment Of 300 Subjects As Part Of The US FDA Pivotal Study Enrollment

DUBLIN--(BUSINESS WIRE)--Presbia PLC (NASDAQ: LENS), an ophthalmic device company and leader in near vision restoration announced today that it is approaching completion of patient enrollment of its U.S. Food and Drug Administration (FDA) pivotal study for the Presbia Flexivue Microlens^TM. Presbia has a proprietary optical lens implant for treating presbyopia, the gradual loss of near vision. The company will submit its Final PMA module to the FDA for approval of the Flexivue Microlens after 300 treated subjects complete the 24-month follow-up visit.

“Completion of enrollment for our pivotal study is progressing on schedule, moving toward a timely submission to obtain FDA approval”

Presbia received FDA approval to commence the second stage of its pivotal study in February of this year, and is continuing to enroll and treat subjects at eleven investigational sites across the United States as well as actively monitor the patients treated as part of the first stage of the pivotal study.

“Completion of enrollment for our pivotal study is progressing on schedule, moving toward a timely submission to obtain FDA approval,” said Todd Cooper, President and CEO of Presbia. “This step is an important milestone in securing FDA approval to market the Flexivue Microlens to consumers in the U.S.”

Presbia is currently marketing the Presbia Flexivue Microlens™ in a number of countries around the world where it has obtained regulatory approval.

Forward-Looking Statements

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. 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.