Staar Surgical Gets Expert Backing for Device

Monrovia-based Staar Surgical Co. won the backing of an expert U.S. government panel for a wick-like device that’s implanted in the eye to treat glaucoma. The Food and Drug Administration advisory panel voted to recommend the agency approve the device for use once glaucoma drugs stopped working. Panelists noted that the device wasn’t directly judged against the surgical treatment now used, making comparisons to that standard treatment difficult. The panelists said the company’s study suggested the device, called AquaFlow, is a safe and effective way to lower intra-ocular pressure in the eye, which can cause blindness if left untreated. Staar Surgical shares fell 31 cents to close at $15.75 on Nasdaq. The FDA usually follows the advice of its expert panels. Staar consultants told the panel that comparing the Staar results to past studies of surgery suggested a benefit to AquaFlow. Still, the lack of direct comparisons to traditional surgery will make it harder to convince doctors that the AquaFlow is the best option, said Ted Huber, an analyst at Banc of America. The company hopes to win approval by early next year, said Steven Ziemba, Staar’s senior vice president of regulatory affairs. Staar had sales of about $60 million last year.