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Presbia completes second stage patient enrollment in Flexivue Microlens study

Ophthalmic device firm Presbia has completed the second stage enrollment in its pivotal study of Flexivue Microlens.

The firm has developed Presbia Flexivue Microlens for treating presbyopia, the age-related loss of near vision.

Presbia president and CEO Todd Cooper said: "Completing the second stage enrollment of our pivotal study is an important milestone in advancing our goal of obtaining FDA approval.

"Securing FDA approval will allow us to provide the Presbia Flexivue Microlens to U.S. consumers as a safe and effective treatment option for presbyopia."

In February this year, the company obtained approval from the US Food and Drug Administration (FDA) to start the second stage enrollment of around 337 qualified subjects in the study.

The firm has enrolled majority of the patients in the trial in less than five months, reaching the target of its required enrollment by the end of the third quarter.

The Presbia Flexivue Microlens obtained CE mark approval, allowing the firm to sell the lens in around 30 countries across Europe.
It is also available in some other countries across the globe, where it received regulatory approvals.