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