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STAAR receives ‘approvable’ letter for Visian ICL phakic lens
Final approval hinges on an FDA inspection of manufacturing facilities. The company had recently responded to an FDA letter regarding violations.
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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.
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, and has been in use internationally for years.
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 company has faced challenges from the FDA over its manufacturing processes lately, having received two letters from the regulatory body since a December 2003 site audit regarding violations at its facilities. STAAR recently responded to an FDA letter regarding what the FDA called “serious, continuing violations.” STAAR has noted in previous releases that FDA approval of the Visian ICL was unlikely to be granted until the manufacturing issues were resolved.
The “approvable” designation came almost 22 months after the ICL was recommended for approval by an FDA advisory panel. In early October 2003, the FDA’s Ophthalmic Devices Panel voted 8 to 3 to recommend approval of the device, with conditions, for correction or reduction of myopia.
Financial report
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.
“During the second quarter we successfully grew our sales year-over-year and sequentially,” said David Bailey, STAAR’s president and chief executive officer, in the financial press release. “International sales of the ICL were, once again, very strong this quarter compared with the same quarter last year, and contributed to our 31% growth in the international markets.”
Mr. Bailey 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. The TICL is a variant of the ICL designed to correct astigmatism as well as myopia.
“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.
Total product sales during the second quarter for STAAR Surgical rose 16% from the same quarter in 2004.
According to the press release, second quarter sales rose from $12 million in 2004 to $13.9 million in 2005. There was a 2% increase in the quarter from $13.6 million in the first quarter.
Response to letter
Earlier in July, STAAR announced that it had received a letter from the FDA dated July 5, stating that the company had “failed to adequately correct numerous violations” that were identified in a site audit in 2004. The letter gave STAAR until July 15 to respond to the FDA.
In a Web cast after that letter was received, Don M. Bailey, STAAR’s chairman of the board, noted that the company was making every effort to comply with the letter.
“We have refocused the entire organization on the need for us to reach full compliance with FDA rules and regulations and conform to both the letter and the spirit of the regulations,” Mr. Bailey said in the Web cast. “I speak for the entire board when I tell you we take these issues with the utmost seriousness and are totally committed to resolving them to the FDA’s total satisfaction.”
According to an 8-K report the company filed with the U.S. Securities and Exchange Commission on July 20, STAAR met the July 15 deadline, directing a response to the FDA about its audit of the company’s Monrovia site.
The response letter, together with 120 exhibits, comprised 15 volumes and provided a substantive and detailed response on each of the 27 sub-observations, the 8-K report stated. The responses included requested documentation, updates on corrective actions in the FDA letter taken by STAAR following the FDA’s inspection and information gathered afterward. According to the 8-K report, the letter received from the FDA on July 5 covered 14 of the 36 observations originally made after the 2004 audit and requested specific information on 27 of the 84 original sub-observations.
“On three points where the FDA disagreed with STAAR’s interpretation of the FDA regulations, STAAR provided information showing compliance with the regulations under the FDA’s interpretation or corrective actions undertaken to achieve compliance in accordance with the perspective provided by the FDA,” the form stated.
For Your Information:
- STAAR Surgical Co. can be reached at 1911 Walker Ave., Monrovia, CA 91016; 626-303-7902; fax: 626-359-8402; Web site: www.staar.com.
- The company’s 8K form, filed with the U.S. Securities and Exchange Commission on July 20, can be found at www.staar.com/index.php?dirflag=ir&sitecode=US.