The 510(k) clearance was based on the results of a multi-center, international clinical trial that established equivalency of titanium:sapphire laser trabeculoplasty (TLT) to argon laser trabeculoplasty (ALT) in the ability to reduce intraocular pressure (IOP) in patients having primary open angle glaucoma and poorly controlled IOP on maximally tolerated medications or prior failed trabeculoplasty.
More than 180 patients were randomized one to one for either ALT or TLT in the trial which was conducted across the US, Europe, Canada, and Israel. The study results showed that in patients at 12 month follow-up, the mean IOP reduction achieved was 6.8 plus or minus 4.7mmHg (25.8%) for TLT versus 5.7 plus or minus 4.8mmHg (22.2%) for ALT.
According to the company, the SOLX 790 Titanium:Sapphire laser emits pulses of energy at a near-infrared 790nm wavelength to loosen particles in the trabecular meshwork without causing significant thermal damage. The energy penetrates deeper into the tissue than other currently used trabeculoplasty lasers, which may lead to longer lasting treatment benefits, the company said.
Doug Adams, president and founder of Solx, said: “This is a significant milestone for Solx. The Solx 790 laser is the cornerstone of our glaucoma management system along with the Solx Gold Shunt.”