Presbia, an ophthalmic device company, announced that it has scheduled the remaining treatments for completing the second stage enrollment of its US 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.