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PMA submitted for corneal inlay
The final module of the premarket approval application (PMA) for the Kamra corneal inlay to treat presbyopia has been submitted to the FDA by AcuFocus, the inlay’s manufacturer.
Irvine, CA-The final module of the premarket approval application (PMA) for the Kamra corneal inlay has been submitted to the FDA by AcuFocus, the inlay’s manufacturer. The corneal inlay is designed to treat presbyopia by allowing only focused light to enter the eye.
“Patients, practitioners, and the ophthalmic industry have all been in search of a reliable corneal solution for presbyopia and I believe the Kamra inlay is that solution,” said John Vukich, MD, an investigator in the U.S. clinical trials.
The inlay is a novel technology with no similar precedent in the market and has undergone rigorous approval processes in several countries. It is now approved in 47 countries across Europe, Asia-Pacific, Middle East, and the Americas.
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