California-based device maker AcuFocus is taking its next-generation intraocular lens to Europe after winning regulatory approval to treat cataract patients with near vision loss, or presbyopia.
The company announced today that it won CE Mark approval in the European Union for its IC-I intraocular lens (IOL), which uses small-aperture technology from AcuFocus’ older Kamra inlay to enhance near-vision without sacrificing distance vision.
"The small aperture effect is a globally accepted method for vision correction," AcuFocus chairman & CEO Jim Mazzo said in prepared remarks. "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 is planning a controlled release in Europe while the company continues to await FDA approval for its flagship Kamra device, a corneal inlay designed to treat presbyopia.
The Kamra device won CE Mark approval in the European Union in 2005. AcuFocus, which raised a $21 million round earlier this month, said it plans to extend its reach in Europe and lay the groundwork for commercialization in the U.S. as it works with the FDA on its bid for pre-market approval.
An FDA advisory panel in June issued a mixed verdict on the Kamra inlay, voting that the device is effective but splitting over its safety. The Ophthalmic Devices panel voted 7-1 that Kamra is effective but required chairman Dr. Neil Bressler to break a tie to make the vote 5-4 against on the safety question. The panel was also divided over the Kamra Inlay’s benefits versus its risks, voting 4-3 with 1 abstention that the benefits top the risks.
