A Medical Device Daily

Clouds of concern continue to cast a large shadow over the future prospects of ophthalmic manufacturer Staar Surgical (Monrovia, California), the company reporting yesterday that it received a letter from the FDA saying that it has “failed to adequately correct numerous violations” previously cited by the agency.

The letter is a reply to the company’s responses – those responses dated Nov. 4, 2004, and Feb. 11, 2005 – to the agency’s concerns resulting from a September 2004 audit of Staar’s Monrovia facility.

The new letter places continuing doubt on the company’s ability to win approval for its phakic intraocular lens (ICL) technology designed to reduce myopia, a technology given a thumbs-up by an FDA panel in late 2003 (Medical Device Daily, Oct. 7, 2003), but since blocked by various agency concerns.

In a statement, Staar said that the letter, received July 5, states that the agency is “gravely concerned about Staar’s serious, continuing violations and is prepared to seek the appropriate remedies.” The letter, Staar said, indicates that it is a “final attempt [by the FDA] to notify Staar of its non-compliance” and gives it 10 days following receipt to provide “responses and supporting documentation.”

David Bailey, president of Staar, in a Monday morning conference call characterized the issues cited by the FDA as falling into three categories: disagreements with the company’s responses, a request for updated status of documentation “on work committed to in previous responses,” and seeking more information than already provided.

He said that the agency was requesting response to 14 of 36 original observations.

The company promised to submit its response by the July 15 deadline. It will include, “among other things, data gathered by Staar and information about ongoing corrective actions taken by Staaar following the latest update submitted to FDA in February 2005.”

Joanne Wuensch, a medical technology analyst with Harris Nesbitt (New York), issued a report calling the letter both “worrisome” and “surprising.”

She said, “given the tone and language” of the letter “it is difficult . . . to understand what is transpiring between Staar and the FDA,” especially since the company “has been working with the Office of Device Evaluation in hopes of an approvable letter” for its ICL technology.

The letter adds to ongoing concerns, highlighted by the company’s own report in March, that its board had hired Morgan Stanley to assist in its review of “strategic and financial alternatives” (MDD, March 7, 2005).

Apparently quite high on the list of alternatives is sale of the company to one of the larger ophthalmic firms, with Bausch & Lomb (Rochester, New York), Alcon (Fort Worth, Texas) and Advanced Medical Optics (Santa Ana, California) among the rumored suitors.

In reporting the recent agency letter, Staar said that it could provide no assurance concerning its ability to resolve the open issues, but board member Donald Bailey emphasized the company’s commitment to resolving the problems as its No. 1 priority.

The company said that if its responses are not considered adequate, it “believes that the FDA will pursue enforcement action” and that “[t]his action, if taken, would most likely have a material and adverse impact upon Staar and its prospects.”

It said it continues to believe that the agency will not give it final approval to market the Visian ICL until the compliance issues are resolved.

While not winning approval in the U.S., the Visian ICL has been CE-marked, is approved for sale in 37 countries and has been implanted in more than 35,000 eyes, according to Staar. It won Korean approval in May (MDD, May 23, 2005).

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