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Federal Trade Commission/Eye Research Associates.

This article was originally published in The Gray Sheet

Executive Summary

Consent agreement proposed by FTC in a Feb. 25 Federal Register notice would settle claims that ERA made "false, unsubstantiated" and "deceptive" claims in direct-to-consumer print advertisements and videotapes in promoting its "Controlled Kerato Reformation orthokeratology (CKR Ortho-K) service. Ortho-K is a non-surgical process in which a patient wears, usually while asleep, custom-designed extended-wear contact lenses that reshape the corneal curvature of the eye. FTC proposes that the company remove from advertisements certain claims, including one stating that the procedure corrects myopia and astigmatism, "thereby permanently eliminating the need for eyewear." FTC is seeking public comment on the proposed consent order by April 27. FDA's Ophthalmology Devices Panel raised concern with Ortho-K at a Feb. 12 meeting; the agency is developing guidance for manufacturers of Ortho-K lenses following a recent FDA decision to require approval of a premarket approval application ("The Gray Sheet" Feb. 23, p. 9)...

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