FDA approves excimer-laser PRK; however . . .

After ten years of development and clinical trials, the US Food and Drug Administration (FDA) gave approval to Summit Technology (Waltham, MA) to market excimer lasers for the correction of nearsightedness using photorefractive keratectomy (PRK). Although Summit is now the only company in the USA with FDA approval for PRK, rival VISX Inc. (Santa Clara, CA) is close behind. When Summit received its good news, VISX also received preliminary approval of its excimer laser from the FDA`s Ophthalmic D

FDA approves excimer-laser PRK; however . . .

After ten years of development and clinical trials, the US Food and Drug Administration (FDA) gave approval to Summit Technology (Waltham, MA) to market excimer lasers for the correction of nearsightedness using photorefractive keratectomy (PRK). Although Summit is now the only company in the USA with FDA approval for PRK, rival VISX Inc. (Santa Clara, CA) is close behind. When Summit received its good news, VISX also received preliminary approval of its excimer laser from the FDA`s Ophthalmic Devices Advisory Panel.

Several conditions were placed on VISX`s preliminary approval, however. The FDA panel voiced concern about the safety and efficacy of the firm`s PRK laser system. Among the conditions set down by the panel are additional review of resubmitted data, postmarket surveillance, and labeling that states that both eyes should not be operated on at the same time.

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