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Refractec ViewPoint Comparative Claims Questioned During Panel Review

This article was originally published in The Gray Sheet

Executive Summary

Reservations raised by FDA's Ophthalmic Devices Panel regarding claims by Refractec about the less invasive nature of its ViewPoint conductive keratoplasty (CK) system compared with LASIK highlight the challenges the firm may face in differentiating its product from other refractive devices for treating hyperopia

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Refractec Viewpoint Hyperopia Approval Limited To Temporary Treatment

Refractec is positioning its Viewpoint CK conductive keratoplasty system as a potentially favorable alternative to LASIK for hyperopia (farsightedness) despite FDA approval limiting the product to "temporary" treatment

Refractec Viewpoint Hyperopia Approval Limited To Temporary Treatment

Refractec is positioning its Viewpoint CK conductive keratoplasty system as a potentially favorable alternative to LASIK for hyperopia (farsightedness) despite FDA approval limiting the product to "temporary" treatment

Refractec ViewPoint Approval Should Reflect Lack Of Long-Term Data – Panel

Refractec should modify the proposed labeling for its ViewPoint conductive keratoplasty system to reflect a dearth of long-term efficacy data, FDA's Ophthalmic Devices Panel recommended Nov. 30 in voting 9-1 for the device's approval

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