DUBLIN--(BUSINESS WIRE)--Presbia PLC (NASDAQ: LENS), an ophthalmic device company and leader in near vision restoration announced that it has scheduled the remaining treatments for completing the second stage enrollment of its U.S. Food and Drug Administration (FDA) pivotal study, a significant milestone in the FDA approval process of its Presbia Flexivue Microlens™. The final surgeries will take place the week of September 7. This announcement was made at the Barcelona 2015 XXXIII Congress of the European Society of Cataract & Refractive Surgeons (ESCRS), Europe’s leading organization for cataract and refractive surgeons with more than 5,000 members from approximately 100 countries.
The Presbia Flexivue Microlens is a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision, and has been commercially available in the European Union and other countries around the world where it has obtained regulatory approval.
“We’ve had considerable momentum in our study enrollment, and the speed of enrollment for this second stage study is one of the fastest study enrollments that I’ve seen in my career,” said Todd Cooper, President and CEO of Presbia. “Additionally, making this announcement at the prestigious ESCRS congress attended by industry leaders is especially gratifying.”
In February, Presbia received FDA approval to commence the second stage pivotal study of its Microlens, which required enrollment of 337 qualified subjects. As the study ramped-up, the majority of the patients were enrolled and treated in less than five months, meeting Presbia’s target to complete the required enrollment by the end of the third quarter.
“Presbia efficiently provided our clinic with patients and any support we needed, making this a quick enrollment and straightforward process,” commented Dr. Michael Gordon, a medical monitor and clinical investigator for Presbia’s study, and ophthalmic surgeon at the Gordon-Weiss-Schanzlin Vision Institute in La Jolla, CA.
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.
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.