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B&L’s Technolas gains expanded U.S. approval
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ROCHESTER, N.Y. — The Technolas 217A Excimer Laser System has been approved for use in the United States for the correction of hyperopia up to +4 D and the treatment of astigmatism up to +2 D when used as part of a LASIK procedure, according to a news release issued by Bausch & Lomb.
The Technolas 217A was initially approved for use in the United States for the treatment of myopia ranging from –1 D to –7 D and less than 3 D of astigmatism. It recently gained an expanded indication for the treatment of moderate to high levels of myopia and is currently approved for the treatment of myopia with astigmatism of up to –12 D spherical equivalent, sphere between –7 D and –0.99 D and cylinder less than –3 D.
The original approval for the Technolas 217A system was based upon a multicenter trial in Canada composed of 377 eyes. Of those, 272 were treated for astigmatic myopia and 105 were treated for spherical myopia. At the 3-month follow-up, 99.4% of the eyes were corrected to 20/40 or better and 84.8% were corrected to 20/20 or better.
Bausch & Lomb is currently waiting for U.S. regulatory approval on the Zyoptix system for customized laser vision correction. Zyoptix combines the Technolas 217 excimer laser with a diagnostic capability and customized treatment calculation program. The system is currently being marketed in Europe, Asia, Latin America and Canada.
For more on the Zyoptix system, click here.