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FDA patient enrollment complete for Solx 790 titanium laser
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STOCKHOLM, Sweden — OccuLogix announced the completion of U.S. Food and Drug Administration clinical trial patient enrollment of its Solx 790 laser for titanium laser trabeculoplasty in a press release here.
The titanium laser trabeculoplasty (TLT) trial is a multicenter outpatient study comparing TLT with argon laser trabeculoplasty (ALT) in IOP reduction in open-angle glaucoma patients, according to the release. The study has enrolled more than 160 eyes each at five centers in the United States, two in Canada, one in Israel and one in Spain.
According to Doug Adams, CEO and founder of Solx, nonrandomized trials of TLT vs. ALT showed about a drop in IOP of 1 mm Hg with TLT over ALT at 6, 12 and 18 months.
"If every mm Hg counts, these results will be important to communicate," Mr. Adams said in an interview with Ocular Surgery News.
Because of the amount of time in development of the laser and then the subsequent enrollment period, Mr. Adams said the completion "is a personal milestone for me. I am very pleased with finishing enrollment."
"The bottom line as far as the efficacy, ALT and TLT are similar, and we had no major complications with TLT," Shlomo Melamed, MD, told OSN. "The advantages of TLT are that it penetrates deeper, lowering pressure very effectively, with no coagulative damage."
The Solx 790 laser is a titanium-sapphire laser that loosens particles in the trabecular meshwork by emitting near infrared light that does not cause thermal damage, according to the press release.