■ ViaLase announced online publication in Ophthalmology Science of 24-month safety data from the first in-human study of femtosecond laser image-guided high-precision trabeculotomy (FLigHT) performed with the ViaLase technology. As reported in the published paper, investigators in this prospective, nonrandomized, single center, interventional, single-arm trial evaluated 11 patients (17 eyes) with open-angle glaucoma following FLigHT treatment. The treatment consists of the creation of a single channel through the trabecular meshwork and into Schlemm’s canal. At 24 months after treatment, the authors reported no device-related serious adverse events and observed well-defined channels with no evidence of closure, indicating medium-term durability. FLigHT is nonincisional, and contrary to prior femtosecond laser studies, causes no collateral damage to surrounding tissue, which may help explain the absence of channel closure observed in this study, according to a news release.
Secondary outcomes included observing intraocular pressure (IOP) at each study timepoint. The data demonstrated a mean IOP reduction of 34.6% from baseline of 22.3±5.5 mmHg to 14.5±2.6 mmHg at 24 months. The IOP reductions observed in this study will be further evaluated as part of the multicenter clinical trial currently under way.
ViaLase also presented data at the 2023 American Glaucoma Society meeting in Austin, Texas, that indicate FLigHT’s potential as a safe and effective treatment option for primary open-angle glaucoma (POAG). The 12-month, prospective, single-center, nonrandomized study was designed to evaluate safety, as well as to observe the IOP-lowering effect of the FLigHT treatment. Nine patients (15 eyes) with POAG or ocular hypertension received the nonincisional procedure after medication washout. Investigators reported no adverse events related to FLigHT treatment and observed a reduction in mean IOP. Additionally, 100% of eyes did not require IOP-lowering medication after 1 year, and gonioscopy revealed no evidence of scarring at the site of treatment.
“We look forward to continuing this important research, with the ultimate goal of bringing a safe and effective noninvasive treatment to glaucoma patients, supported by a multicenter prospective randomized trial which is currently enrolling,” Richard Lewis, MD, chief medical officer of ViaLase, said in a news release.