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Visx gets U.S. wavefront approval, defeats Icahn board nominee
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SANTA CLARA, Calif. — The CustomVue laser vision correction system has been granted regulatory approval by the Food and Drug Administration, manufacturer Visx announced late last week. The same day, the company announced that it has fought off another advance by corporate financier Carl Icahn.
A Wall Street Journal report indicated that, in response to shareholders’ rejection of his candidate for the board of directors, affiliates of Mr. Icahn sold an 11.7% stake – or just over 6 million shares – in the company on May 28 to an unspecified investment banking firm.
The CustomVue system uses the WaveScan diagnostic system, Visx’s wavefront software. According to a Visx news release, clinical data showed that at 1 year postoperatively, all follow-up examinations indicated participants could pass a driving test without glasses or contacts. In addition, 98% of patients could see 20/20 or better, and 70% had better than 20/20 vision without correction.
The FDA granted approval for WaveScan diagnosis and CustomVue for the treatment of patients with myopia and astigmatism. Visx executives noted that trials are under way with the system to correct hyperopia as well.
The Visx wavefront system is the second to be granted U.S. regulatory approval. The FDA approved Alcon’s CustomCornea wavefront system in October.
In other Visx news, stockholders rejected by a large margin a nominee proposed by Mr. Icahn to replace one of the current members of the Visx board of directors, based on the proxies submitted to an independent inspector. Mr. Icahn has made repeated attempts to replace Visx board members in the past several years. The company also said it believes proposals to amend its director option plan and its stock plan were ratified as well.