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Staar back on PMA (pre-market approval) track with Visian?

This article was originally published in Clinica

Executive Summary

Ophthalmic company Staar Surgical may soon see an end to its long struggle to get approval for its Visian implantable contact lens (ICL). The FDA has determined that the device is approvable, following a review of the firm's pre-market approval (PMA) application for the product. However, the final thumbs up will only be given if the company passes an FDA manufacturing facilities inspection. Investors welcomed this news by giving the company's stocks a much-needed boost, as Staar's share price closed at an all-month high of $5.28 on July 29, the day after the announcement.

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