GAITHERSBURG, Maryland – Bausch + Lomb (B+L, Rochester, New York) nailed an advisory committee vote in favor of the firm's Trulign intraocular lens despite hundreds of protocol violations, snaring 10 "aye" votes out of a possible 12 that the benefits of the device outweighed the risks. FDA said that the pivotal trial racked up 28 major and 373 minor protocol deviations, including enrollment of 11 patients who did not meet enrollment criteria, as well as the use of non-study lenses in the trial. However, the study article beat out the control device in recovery of vision for two measures of diopter, an outcome that carried the day when combined with the safety data. Read More
