OccuLogix completes patient enrolment for glaucoma laser trial

OccuLogix today announced the completion of enrolment for the SOLX 790 titanium laser trabeculoplasty (TLT) clinical trial, which the firm hopes will support its application for 510(k) clearance with the FDA.

SOLX 790 is already commercially available in Europe and Canada.

The laser is currently being assessed for intraocular pressure (IOP) reduction ability in comparison to argon laser trabeculoplasty (ALT). According to the firm, TLT has so far shown consistent, equivalent IOP reduction in patients followed for up to one year in a randomised study.

The current trial is a US FDA, multicentre, outpatient study assessing equivalency of TLT to ALT in IOP reducing ability in primary open angle glaucoma patients who are poorly controlled on maximally tolerated medications and/or who have failed prior glaucoma surgery. More than 160 eyes have been enrolled in sites across the US and Canada and also in Israel and Spain. Half of patients have been randomised to receive TLT therapy.

"In my experience, patients treated with SOLX 790 achieve an immediate reduction in IOP and these levels are maintained for up to 12 months," according to Israeli investigator Modi Goldenfeld, MD. "The ability of this laser to lower and maintain IOP levels without causing thermal damage is very important."

The SOLX 790 laser is a titanium-sapphire laser that emits near-infrared light at the 790 nm level to loosen particles in the trabecular meshwork, without causing thermal damage, and penetrating deep into tissue, to a depth of approximately 200 microns. According to CEO and Founder of SOLX, Doug Adams, this is the first laser of its kind to demonstrate these features.