APPROVAL OF EXPANDED PRK INDICATIONS BASED ON 100-200 PATIENTS, SUGGESTED BYPANEL; "OFFSHOOT" INDICATIONS INCLUDE HIGH MYOPIA, ASTIGMATISM
This article was originally published in The Gray Sheet
Executive SummaryClearance of additional indications for excimer lasers approved for photorefractive keratectomy could be based on studies with as few as 100-200 patients followed up for six months, FDA's Ophthalmic Devices Panel concluded at a July 26 meeting in Gaithersburg, Maryland.
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