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AcuFocus Small Aperture IOL Receives CE Mark for Europe

Irvine, Calif. – September 11, 2014 –AcuFocus, Inc., the global leader in small-­‐ aperture technology, today announced that its extended depth of focus intraocular lens (IOL), the IC-8® small aperture IOL, has achieved CE Mark (Conformité Européenne) approval in Europe. The lens is designed to provide exceptional visual quality across a broad range of vision for presbyopic patients with cataracts.

AcuFocus’ flagship product, the KAMRA inlay, has already established that the small aperture effect provides predictable and reliable improvement in near vision while maintaining distance vision.1 By applying the same principle, the AcuFocus IC-­‐8 IOL increases the population of patients who can benefit from small aperture optics.

Like presbyopia, most patients will develop cataracts over time, inhibiting their ability to see clearly at any distance. By 2015, it is estimated that over 24 million cataract procedures will be performed worldwide with nearly 4 million of those procedures taking place in Europe.2 Treatment options for the cataract patient today come with a range of compromises, including incomplete range of vision, disabling visual quality degradation from induced glare and halo, and loss of binocular contrast. The IC-­‐ 8 IOL was designed to address these limitations and return high quality, continuous functional vision.

“The small aperture effect is a globally accepted method for vision correction,” said Jim Mazzo, Chairman and CEO of AcuFocus. “The KAMRA inlay is the ideal solution for presbyopic patients who don’t want or require lens removal. With the addition of the IOL to our patented small aperture portfolio, we can now provide cataract patients with the same exceptional vision.”

AcuFocus plans to make the IC-­‐8 IOL available through a controlled release in select markets across Europe.  The IC-­‐8 IOL is not approved for use in the United States.

References

  1. Vukich et “Achieving Reliable and Predictable Results with a Small Aperture Inlay” 2014 AcuFocus white paper.
  2. 2014 Comprehensive Report on the Global IOL Market, Market Scope®, LLC