STAAR Surgical’s AQUA-FLOW collagen glaucoma drainage device, approved for use in Europe to reduce intraocular pressure in glaucoma patients, is earning kudos from experts.

Favorable data concerning the device were presented at the European Society of Cataract and Refractive Surgeon Conference in Vienna, Austria. A 3-year Swiss study of 100 patients found that patients with a preoperative mean pressure of 27 mm Hg demonstrated a significant reduction in mean pressure, to 13 mm Hg, and sustained this level. An American study for FDA clinical trials, conducted at the Shepard Eye Center in Santa Maria, Calif., found that while all patients preoperatively needed an average of two and a half medications, four out of five required no medications postoperatively. The remaining patients needed to take only one medication.

STAAR Surgical has completed enrollment for its FDA clinical study of the AQUA-FLOW and believes that the data merit presentation to the FDA after 1-year follow-up instead of the normal 2 years. STAAR Surgical will therefore prepare data for a Pre-Market Approval presentation.

The AQUA-FLOW device is implanted as part of a nonpenetrating surgical procedure. The studies indicate that the sooner it’s used after the initial diagnosis of open-angle glaucoma, the better. It also carries a much lower risk of complications than such treatments as conventional glaucoma filtering surgery.

John R. Wolf, chairman and president of the company, says, "The data presented by leading ophthalmologists confirms our belief that the AQUA-FLOW device is the best long-term treatment for glaucoma. The AQUA-FLOW reduces intraocular pressure and the need for postoperative medications while preventing blindness. This data confirms the very positive benefits for ophthalmologists around the world and the more than 67 million people who have been diagnosed with this disease."