Presbia PLC announced that all subjects treated as part of the first stage of its U.S. Food and Drug Administration (FDA) pivotal study completed their 12-month postoperative visits, a significant milestone in the FDA approval process of its Presbia Flexivue Microlens. The Presbia Flexivue Microlens is a revolutionary optical lens implant for treating presbyopia, the age-related loss of near-vision. The Microlens has received regulatory approval and is commercially available in more than 40 countries across Europe, Asia Pacific, Latin America, the Middle East and Africa.

The FDA permitted Presbia to conduct its pivotal study in two stages. The first stage had an enrollment of 75 subjects and the second stage an additional 346 subjects. The second stage enrollment was completed in early September 2015 and those participants will begin their 12-month postoperative visits this month.