US-based AcuFocus has submitted the KAMRA intra-corneal inlay’s final premarket approval application (PMA) module to the US Food and Drug Administration (FDA).
KAMRA is an opaque circular micro-disc with a small opening (1.6mm) in the centre and, when placed in the cornea, blocks unfocused light, only allowing focused light to reach the retina.
The device helps patients to regain the reading vision they had prior to presbyopia, and allows them to perform daily activities such as reading text messages, checking the time on a wristwatch and reading store shelf prices without glasses.
US clinical trials investigator John Vukich said; “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.”
AcuFocus CEO and president Ed Peterson said; “After 10 years of development and thousands of patients treated globally, it is incredible to finally be able to submit this last module to the FDA for US approval.”
AcuFocus chief clinical officer Corina van de Pol said KAMRA is the first corneal inlay for treatment of presbyopia submitted for US approval.
“We look forward to working with the FDA throughout the review process,” van de Pol said.
The device is currently available for sale in 47 nations around the world.