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FDA panel gives CK “approvable” recommendation

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WASHINGTON — Refractec's ViewPoint CK system for conductive keratoplasty received an "approvable with conditions" vote from a government panel here on Nov. 30.

The Ophthalmic Devices Panel of the Food and Drug Administration voted 9 to 1 to approve the device with conditions. Among the conditions specified was that the labeling include the wording “for the temporary reduction of hyperopia.”

The ViewPoint CK system uses radio frequency energy to treat spherical hyperopia between 0.75 D and 3 D.

The panel's chief concern was the device’s efficacy. The 12-month follow-up data Refractec provided did not convince the panel that the ViewPoint CK System could maintain a refractive change in hyperopes for longer than a brief window of time.

Panel members noted that the ViewPoint CK System induces overcorrection in the early postop period, and patients must then wait for regression to occur. The regression may continue past the surgical goal and possibly continue beyond the 12-month mark.

Refractec did not provide 24-month follow-up data on regression.