Presbia PLC has announced that all 421 subjects treated with the Presbia Flexivue Microlens as part of its U.S. Food and Drug Administration (FDA) pivotal study completed their 6-month post-operative visits, one step closer to making the submission of its final PMA module to the FDA in approximately 18 months. The Presbia Flexivue Microlens is a revolutionary optical lens implant for treating presbyopia, the age-related loss of near-vision. Once 300 of the 421 subjects complete their 24-month post-operative visits and after the related data has been compiled, Presbia will submit its final PMA module to the FDA, which is anticipated in fourth quarter of 2017. Presbia is concurrently pursuing a focused approach to its commercial strategy outside of the U.S. with activities taking place in South Korea, followed by Germany, which will demonstrate the superiority, safety, and efficacy of Presbia's Microlens technology.