www.fdanews.com/articles/173056-presbia-completes-second-stage-enrollment-of-optical-lens-implant-study
Presbia Completes Second Stage Enrollment of Optical Lens Implant Study
September 10, 2015
Ophthalmic device company Presbia has completed the second stage enrollment of its FDA pivotal study as it seeks approval from the agency for its Presbia Flexivue Microlens.
Presbia received FDA approval in February to begin the second stage pivotal study of its microlens, which required enrollment of 337 qualified subjects.
The microlens is an optical lens implant for treating presbyopia, the age-related loss of near vision.
The device is commercially available in the European Union and other countries around the world where it has obtained regulatory approvals. — Michael Cipriano