Friday, September 19, 2008

Solx wins FDA OK to sell glaucoma treatment laser

By Mass High Tech Staff

Ophthalmology medical device firm Solx Inc. received U.S. Food and Drug Administration approval to market its advanced laser for the treatment of glaucoma, officials report.

The Waltham-based company’s laser, called Solx 790, received 510(K) clearance from the FDA after having proven its equivalence to an already approved method, argon laser trabeculoplasty (ALT). Glaucoma is a disease of the optic nerve involving the degeneration of the retina due to intraocular pressure. Both treatment methods reduce intraocular pressure while preserving critical trabecular tissue, but Solx’s treatment penetrates deeper into eye tissue than current methods, the company said. That may lead to fewer treatments, they added.

The 510(k) clearance was based on the clinical studies enrolling 180 patients in the U.S, Canada, Europe and Israel. The Solx 790 laser emits pulses of energy at a near-infrared (790 nm) wavelength to loosen particles in the trabecular meshwork without causing significant thermal damage. Solx 790 is already approved in Europe and Canada

Solx was based at Boston University’s Photonics Center since 2000. Canada-based OccuLogix Inc. acquired Solx in 2006. In the U.S., three million people suffer from glaucoma; worldwide, the figure is 70 million, according to the company.