Nov 13 2013
PresbiBio LLC, a wholly owned subsidiary of Presbia Holdings, a medical device company and leader in near vision restoration, announced today that it has received conditional approval from the United States Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) application to commence a Phase II trial of the Presbia Flexivue Microlens™, a corneal inlay.
“This is an important step in making the Presbia Flexivue Microlens™, a refractive solution for the treatment of presbyopia intended to reduce the dependency on reading glasses, available to more patients affected by this common age-related deterioration of near vision,” said Vlad Feingold, Chief Technology Officer and inventor of the product.
PresbiBio plans to begin its Phase II trial in the first quarter of 2014 with Dr. Mickey Gordon and Dr. Robert Maloney as Co-Medical Monitors. The Presbia Flexivue Microlens™ received the CE Mark in 2009, making it commercially available in 40 countries across Europe and Latin America.
ABOUT PRESBIA AND THE PRESBIA FLEXIVUE MICROLENS™
Presbia Holdings is a leading ophthalmic-device company focused on the development of solutions for presbyopia, the age-related loss of the ability to read or focus on near objects. Chief among these approaches is the Presbia Flexivue Microlens™, a 3mm-diameter lens that is implanted in the corneal stroma of the patient’s non-dominant eye using femtosecond laser technology. The procedure requires no general anesthesia and typical recovery periods are only a few days. The Presbia Flexivue Microlens™ solution utilizes existing equipment and ophthalmic surgical techniques, and requires only minimal additional staff training.
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