Health Canada for AcuFocus' treatment for presbyopia
AcuFocus has secured approval from Health Canada to market and sell the Kamra inlay within Canada. At the same time, the company has obtained a certificate of free sale, which will now open up additional markets such as Argentina, Russian Federation, Venezuela, Peru, Mexico, India and Colombia.
The Kamra inlay is a treatment option that uses small aperture optics to restore near and intermediate vision. It offers a treatment option for presbyopia, a naturally frustrating condition affecting millions of people over 40, resulting in the loss of near vision. It is caused by changes that occur within the proteins of the eyeâs natural lens, making the lens gradually thicker and less elastic over time. With less flexibility, the eye has a harder time focusing up close. As a result, presbyopes become dependent upon reading glasses for most everyday near tasks. According to AcuFocus, presbyopia currently affects approximately 40 per cent of Canadians, representing nearly 14 million people.
To date, the Kamray inlay has been implanted in more than 15,000 patients and is now available in over 40 countries worldwide. The inlay has CE mark approval and is available in selected markets across Europe, Asia-Pacific, Middle East and South America. The company anticipates submitting for FDA clearance for the US market in the fourth quarter of 2012.