ViaLase, Inc., a clinical stage medical technology company focused on addressing unmet needs in the conventional glaucoma treatment paradigm with the development of a truly noninvasive image-guided femtosecond laser treatment to enhance glaucoma patient care, today announced the online publication 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 in Ophthalmology® Science, a journal of the American Academy of Ophthalmology.
"We are encouraged by the outcomes of this safety analysis of our first in-human study and pleased to have the data made publicly available to the ophthalmic community," said Richard Lewis, MD, Chief Medical Officer, ViaLase, Inc. "This initial pilot study, along with our currently enrolling multi-center prospective randomized trial, are both important components of our efforts to evaluate the safety and efficacy of the ViaLase technology performing the first and only FLigHT treatment and understand its potential as a novel, noninvasive treatment for glaucoma patients."
ViaLase's FLigHT treatment leverages the precision and accuracy of both a femtosecond laser and advanced imaging technology in a noninvasive procedure. As reported in the published paper, investigators in this prospective, non-randomized, single center, interventional, single arm trial evaluated 11 patients (17 eyes) with open angle glaucoma following FLigHT treatment, which consisted of the creation of a single channel through the trabecular meshwork and into Schlemm's canal. At 24 months post-treatment, the authors reported no device-related serious adverse events and observed well-defined channels with no evidence of closure, indicating medium-term durability.
"Unlike surgical procedures that require opening the eye, FLigHT is non-incisional and leverages the proven track record of the safety and precision of femtosecond laser technology, which are no doubt factors that contributed to these favorable safety results," said Professor Zoltan Z. Nagy, MD, PhD, Chair of the Department of Ophthalmology, Semmelweis University in Budapest, and lead author. "Another potentially contributing factor is the lack of collateral damage to surrounding tissue seen in previous femtosecond laser studies, which may help explain the absence of channel closure observed in this study, as well."
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 to 14.5 ± 2.6 mmHg at 24 months. The IOP reductions observed in this study are encouraging and will be further evaluated as part of the multicenter clinical trial currently underway.
Read the full news release here.