Deficient Long-Term Data Render Sunrise Hyperopia Tool Not Approvable
This article was originally published in The Gray Sheet
Executive Summary
Forty-six percent of the eyes treated with Sunrise Technologies' Hyperion laser thermal keratomileusis (LTK) system for hyperopia in clinical trials were under-corrected by greater than 1.00 diopter twenty-four months post-treatment, data contained in the firm's premarket approval application showed.