Irvine, CA – AcuFocus, Inc. (www.acufocus.com), 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.
About Presbyopia
Presbyopia occurs as part of the normal aging process and occurs when the crystalline lens of the eye loses its flexibility, making it difficult to focus on close objects. Presbyopia may seem to occur suddenly, but the actual loss of flexibility takes place over a number of years, usually becoming noticeable in the early to mid-40’s. Presbyopia is not a disease and cannot be prevented. Traditionally, most people with presbyopia use reading glasses or bifocals to improve their near vision.
About Cataracts
A cataract is characterized by clouding of the eye’s natural crystalline lens resulting in progressive vision loss. Cataracts are the most common cause of blindness worldwide. Cataract surgery requires removal of the natural lens and replacement with a lens implant referred to as an intraocular lens or IOL. Traditionally, a monofocal IOL is used providing patients with good distance vision; however, glasses are required to see objects up close.
About AcuFocus
AcuFocus, Inc., a privately held company located in Irvine, CA, developed the KAMRA inlay for the treatment of near vision loss (presbyopia). The KAMRA™ inlay is an intra-corneal inlay designed to create a small aperture effect, allowing the eye to see near objects more clearly while maintaining distance vision. By applying the "depth-of-focus" principle commonly used in photography, the KAMRA inlay controls light transmission, allowing only central rays to reach the retina through a fixed 1.6 mm aperture. The KAMRA inlay is not yet approved for sale in the United States and is pending FDA approval. AcuFocus has also developed a presbyopia-correcting intraocular lens, the IC-8™ IOL, that uses the same small aperture effect and would be appropriate for patients undergoing cataract surgery or refractive lens exchange. The company developed the AcuTarget HD™ instrument in collaboration with Visiometrics. It combines five diagnostic tools into one state-of-the-art instrument to provide clinicians with objective data to support KAMRA inlay patient selection, centration and post-operative management. The AcuTarget HD instrument is available for sale in many countries worldwide, including the United States. For more information about the KAMRA inlay and AcuTarget HD instrument from AcuFocus, please visit www.acufocus.com. KAMRA and AcuTarget HD are trademarks of AcuFocus, Inc.
References
- Vukich et al. "Achieving Reliable and Predictable Results with a Small Aperture Inlay" 2014 AcuFocus white paper.
2014 Comprehensive Report on the Global IOL Market, Market Scope®, LLC
Press release via AcuFocus.