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Presbia set to complete second stage enrollment for presbyopic lens
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BARCELONA — Presbia announced here that it has scheduled final surgeries for implanting the Flexivue MicroLens, which will complete the second stage of enrollment for the FDA pivotal study.
In February 2015, the FDA gave Presbia approval to begin the second stage study of the hydrophilic corneal inlay that is implanted in the non-dominant eye for the correction of presbyopia. The lens has a power range of 1.5 D to 3.5 D and is placed in a pocket created by a femtosecond laser.
Todd Cooper, Presbia’s president and CEO, told Ocular Surgery News that the enrollment went quickly.
On average, patients gain about six lines of vision, Cooper said, and the product can be removed.
“In 5 years’ time, if your vision continues to deteriorate I can get you back to exactly where you want to be again” by removing the current lens and replacing it with a stronger prescription, Cooper said.
Feedback from patients who have received the lens includes the phrases “freedom from reading glasses” and “confidence,” Cooper said, noting that “part of confidence is feeling and looking young.”
“There is a huge market need for it [Flexivue MicroLens],” Cooper said. “There is also a need and desire for practices to have a solution for their patients who are not in their 20s to 40s and not 65 plus. You don’t need additional capital equipment as many of the top refractive practices have a femtosecond laser.”
“Presbia efficiently provided our clinic with patients and any support we needed, making this a quick enrollment and straightforward process,” Michael Gordon, MD, medical monitor for Presbia and clinical investigator for the study, said. — by Joan-Marie Stiglich, ELS
Disclosure: Cooper reports he is president and CEO of Presbia. Gordon reports he is Presbia’s medical monitor and a clinical investigator for the clinical study.