FDA OKs Phase II Trial for a Corneal Inlay for Presbyopia
PresbiBio LLC 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. 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. Read more.