STAAR Surgical sales up for year, down in fourth quarter

MONROVIA, Calif. — STAAR Surgical reported product sales for full-year 2003 of $50.4 million, up 5% from 2002, according to a company press release. Total revenue for fiscal 2003 was $40.5 million, compared to $48.2 million in 2002.

Sales during the fourth quarter of 2003, however, were $12.8 million, down from $13.2 million reported during fiscal 2002.

The company’s Collamer lens sales increased 18% during the fourth quarter from the year-ago period, and Visian ICL sales were up 20% in the same time period, said David Bailey, president and chief executive officer of STAAR.

Mr. Bailey noted that U.S. IOL sales have been hampered by “the lack of effective injection systems,” but in Europe the company’s preloaded silicone lens system was launched late last year and early sales are positive.

STAAR completed a root-cause analysis after receiving a warning letter from the Food and Drug Administration and was “able to conclude that our patented Collamer material was not the underlying cause of the 26 reported incidents, out of more than 160,000 lenses implanted, concerning certain post-surgical refractive changes,” Mr. Bailey said in the press release. He also indicated the FDA would likely conduct an audit of STAAR’s Nidau, Switzerland, manufacturing facility for the Visian ICL.

“We believe a successful audit of this facility will be a requirement for ICL approval,” Mr. Bailey said.