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.

Health Canada Approves Corneal Inlay for Presbyopia

AcuFocus, Inc. (www.AcuFocus.com), maker of a corneal inlay for the treatment of near vision loss (presbyopia), has received approval from Health Canada to market and sell the Kamra inlay within Canada. They announced further that they have received a certificate of free sale, which will now open up additional markets such as Argentina, Russian Federation, Venezuela, Peru, Mexico, India and Colombia. The inlay uses small aperture optics to restore near and intermediate vision.