09.10.15
Presbia plc, an ophthalmic device company, has completed the second stage enrollment of its U.S. Food and Drug Administration (FDA) pivotal study. The trial is part of the company’s effort to gain approval for its Presbia Flexivue Microlens.
In February, Presbia received FDA approval to commence the second stage of this study, which required enrollment of 337 qualified subjects. As the study ramped up, the majority of the patients were enrolled in less than five months, meeting Presbia’s target to complete the required enrollment by the end of the third quarter.
“Completing the second stage enrollment of our pivotal study is an important milestone in advancing our goal of obtaining FDA approval,” said Todd Cooper, president and CEO of Presbia. “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.”
“Presbia’s professionalism in handling the study enrollment as well as its well-documented procedures made this a process that ran seamlessly,” commented Robert Maloney, M.D., Presbia’s primary medical monitor and investigator participating in the Presbia study, and a surgeon at Maloney Vision Institute, Los Angeles, Calif.
The Presbia Flexivue Microlens is an optical lens implant for treating presbyopia, the age-related loss of near vision. The product is commercially available in the European Union and certain other countries around the world where it has obtained regulatory approvals.
In February, Presbia received FDA approval to commence the second stage of this study, which required enrollment of 337 qualified subjects. As the study ramped up, the majority of the patients were enrolled in less than five months, meeting Presbia’s target to complete the required enrollment by the end of the third quarter.
“Completing the second stage enrollment of our pivotal study is an important milestone in advancing our goal of obtaining FDA approval,” said Todd Cooper, president and CEO of Presbia. “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.”
“Presbia’s professionalism in handling the study enrollment as well as its well-documented procedures made this a process that ran seamlessly,” commented Robert Maloney, M.D., Presbia’s primary medical monitor and investigator participating in the Presbia study, and a surgeon at Maloney Vision Institute, Los Angeles, Calif.
The Presbia Flexivue Microlens is an optical lens implant for treating presbyopia, the age-related loss of near vision. The product is commercially available in the European Union and certain other countries around the world where it has obtained regulatory approvals.