Presbia announced that it received approval from the US Food and Drug Administration (FDA) to commence second stage enrollment in the pivotal trial of the Presbia Flexivue Microlens.
Subjects in stage one of the pivotal trial continue with the Microlens, and are actively being followed.
"With this approval, we will continue enrollment in our pivotal trial taking us one step closer towards gaining FDA approval of our product in the U.S.," said Todd Cooper, President and CEO of Presbia.
"Pending FDA approval, we intend to make the Presbia Flexivue Microlenscommercially available to U.S. presbyopic patients to improve their near vision, and to reduce their dependency on reading glasses."
Presbia 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 US clinical trial for the Presbia Flexivue Microlens commenced in 2014.