Presbia PLC announced that it is approaching completion of patient enrollment of its U.S. Food and Drug Administration (FDA) pivotal study for the Presbia Flexivue MicrolensTM. 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.

The company received FDA approval to commence the second stage of its pivotal study in February of 2016, 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.