Pharmaceutical Business Review
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.