TLT laser receives FDA clearance

September 23, 2008

SOLX 790, a glaucoma laser, has received 510(k) clearance from the FDA and can now be used for Titanium:Sapphire laser trabeculoplasty (TLT) in the United States, the laser's manufacturer, SOLX, has announced.

SOLX 790, a glaucoma laser, has received 510(k) clearance from the FDA and can now be used for Titanium:Sapphire laser trabeculoplasty (TLT) in the United States, the laser's manufacturer, SOLX, has announced. The laser had already been licensed for use in the EU and Canada.

A randomized international multicentre trial enrolled more than 180 subjects to compare TLT with argon laser trabeculectomy (ALT) for intraocular pressure (IOP) reduction. Study subjects had primary open angle glaucoma and poorly controlled IOP on maximally tolerated medications and/or prior failed trabeculoplasty.

At the 12 month follow-up visit, subjects in the TLT treatment arm had achieved a mean IOP reduction of 25.8% (6.8±4.7 mmHg), which had been achieved immediately and maintained throughout the study period; ALT-treated subjects experienced an IOP reduction of 22.2% (5.7±4.8 mmHg). The laser was also found not to cause thermal damage to the trabecular meshwork.

As the TLT treatment was found to be equivalent to ALT treatment, FDA approval for the SOLX 790 laser was granted.