According to the company, the outcomes reported demonstrate a favorable safety profile for its novel, noninvasive glaucoma treatment.
ViaLase Inc. announced the online publication of 24-month safety data from the first-in-human study of femtosecond laser image-guided high-precision trabeculectomy (FLigHT) performed with the ViaLase technology.
The data was released in Ophthalmology Science, a journal of the American Academy of Ophthalmology.
Richard Lewis, MD, chief medical officer, ViaLase, said the company is encouraged by the outcomes of the safety analysis of our first, in-human study and pleased to have the data made publicly available to the ophthalmic community.
“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,” Lewis said in the news release.
Moreover, 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 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.
Zoltan Z. Nagy, MD, PhD, chairman of the Department of Ophthalmology, Semmelweis University in Budapest, and lead author, noted in the news release the study demonstrates to procedure’s safety profile.
"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," Nagy said in the release. "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.