US FDA approves AcuFocus KAMRA corneal inlay for presbyopia

The US Food and Drug Administration has approved the KAMRA corneal inlay, which uses a small-aperture concept to increase depth of focus in presbyopic patients, AcuFocus Chairman and CEO Jim Mazzo announced at the 2015 American Society of Cataract and Refractive Surgery Symposium in San Diego. The approval makes the device available for the first time in the US market, though it has been available in Europe for several years.

In development for 15 years at a total cost of $160 million, the KAMRA device submitted to the FDA is the sixth version, Mazzo said. To date it has been implanted in more than 20,000 patients worldwide, making it the number one corneal implant globally, he added.

The approval was based on the results of 508 patients treated at 24 centres around the world. The device was implanted in the non-dominant eye of patients emmetropic patients, defined as between +0.5 and -0.75 dioptre uncorrected distance vision. Patients in the study experienced an average improvement in uncorrected near visual acuity of 3.0 lines at their 12-month follow up visit, and the improvement was maintained over the five year study. Mean pre-operative distance vision was maintained in the implanted eye at all follow up points.

Safety standards were also high, with the comparator essentially use of reading glasses. Overall, about 2.0 per cent of patients in the study had the inlay explanted, mostly for dissatisfaction with the results rather than medical issues, said John Vukich MD, who served as the study’s medical monitor.

Mazzo praised the FDA for approving the device one month ahead of its initial timeline. “Approving a first-of-its-kind device is very difficult. I have never seen a more cooperative environment.” The level of cooperation demonstrated by the current FDA team bodes well for new devices in the pipeline, he added.

In addition to opening access to the vast US market, the rigor of the FDA approval process is a boost, Mazzo said. “This really validates the small aperture approach to presbyopia treatment. It’s amazing what an FDA approval can do for a small company.”