STAAR receives ‘approvable’ letter for Visian ICL

MONROVIA, Calif. — STAAR Surgical Co. has received an “approvable” letter from federal regulators for its Visian ICL posterior chamber phakic IOL, the company announced.

Final approval of the device is subject to an inspection that finds STAAR’s “manufacturing facilities, methods and controls” to be in compliance with the Food and Drug Administration’s quality requirements, according to a press release from the company on July 28.

According to STAAR, if approved, the Visian ICL will be indicated for the correction of myopia ranging from –3 D to –15 D and for the reduction of myopia from –15 D to –20 D, with astigmatism of 2.5 D or less, in adults 21 to 45 years of age with an anterior chamber depth of at least 3 mm and a stable refractive history for 1 year.

The posterior-chamber phakic IOL, originally named the Implantable Contact Lens and since re-branded as the Visian ICL, has received regulatory approval in some 40 countries, including Canada and all of Europe, according to STAAR.

In a separate press release also dated July 28, STAAR announced its financial results for the second quarter of 2005.

International sales of the Visian ICL increased by 67% compared with the second quarter of 2004 and 21% compared with the first quarter of 2005, and this represented 12% of total sales for the quarter, according to the company.

David Bailey, STAAR’s president and chief executive officer, noted that the recent marketing approval for the Visian Toric ICL (TICL) in South Korea and Canada and the approval of the TICL and ICL in Singapore were catalysts for the growth.

“These approvals should drive further growth in sales and market share internationally, particularly for the TICL, which accounted for 24% of total Visian sales during the second quarter,” Mr. Bailey said in the financial press release.

Total product sales during the second quarter for STAAR Surgical rose 16% from the same quarter in 2004.