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The FDA recently approved the KAMRA inlay corneal implant by AcuFocus Inc. The device is designed to improve near vision by extending the depth of focus in older patients with presbyopia who have emmetropic refractions. The system is an alternative for patients who have not received cataract surgery. But the FDA warns that the device should not be used by patients with severe dry eye disease as this can cause further complications. Presbyopia is a condition associated with ageing in which the eye is unable to focus clearly on near objects.
“Presbyopia is a natural part of ageing and can make reading and performing close-up work difficult,” said William Maisel, M.D., deputy center director for science in the FDA’s Center for Devices and Radiological Health. “The KAMRA inlay provides a new option for correcting near vision in certain patients.”
The primary use of current corneal inlays is to improve near vision and reduce the need for reading glasses in older adults who have presbyopia.
“The [inlay] is the number-one implanted corneal inlay globally,” said Jim Mazzo, chairman and chief executive officer of AcuFocus. “After a decade of research, development, and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the United States.”
To view the full FDA press release, click here
AcuFocus Inc. is a privately held ophthalmic medical device company that develops and markets breakthrough technologies for the improvement of near vision. The Company’s proven, proprietary technology platform uses a small aperture – or pinhole – effect to allow focused light rays to reach the retina and bring objects into focus. The results is unique, reliable and long-term. Using this small aperture concept, two products have been developed: the Company’s flagship product, the KAMRA™ corneal inlay, and the innovative IC-8™ IOL. The KAMRA inlay helps presbyopic patients restore their near vision while maintaining their distance vision. The IC-8 IOL* is specifically designed for patients with cataracts. In addition to these products, AcuFocus also distributes the AcuTarget HD™ diagnostic and surgical planning instrument. This instrument is essential for the optimal treatment and technology selection for a broad range of patients, including LASIK, cataract, dry eye and presbyopes.
About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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