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CK for presbyopia recommended for approval
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GAITHERSBURG, Md. — Treatment of presbyopia with the ViewPoint CK System was recommended for approval, with conditions, late last week by an advisory panel to the Food and Drug Administration.
The Ophthalmic Devices Panel voted unanimously to recommend the system for approval for this additional indication. (The device was previously approved by the FDA in 2002 for use in hyperopia.) According to Refractec, the device’s marketer, the panel recommended approval of the ViewPoint system to perform conductive keratoplasty for the improvement of near vision in emmetropic presbyopes and hyperopic presbyopes. Conductive keratoplasty, or CK, is a radiofrequency treatment that reshapes the cornea.
According to Refractec medical monitors Daniel Durrie, MD, and Marguerite McDonald, MD, the CK procedure has already been used off-label for hyperopic presbyopia and emmetropic presbyopia in “hundreds of procedures.”
The panel’s discussion and recommendations were based on the results of a study with 12-month follow-up in which CK demonstrated effectiveness in “significantly improving a patient’s near vision,” according to a Refractec press release. At 1 year in the study, 95% of patients could see J5, and 83% of patients could see 20/20 and read J3. There were no reported serious, sight-threatening or unanticipated safety events, according to Refractec.
The panel agreed with Refractec that the intended range of correction for the presbyopic procedure should be 1 D to 2.25 D.
The conditions imposed by the panel pertained to the device’s labeling. The panel stressed the importance of educating patients that the long-term effects of CK are unknown, and the effects of the procedure may be temporary. Refractec is to provide additional data in this area.