ViaLase, Inc announced the release of 24-month safety data from the first-in-human (FIH) study of femtosecond laser image-guided high-precision trabeculectomy (FLigHT)—performed using ViaLase technology—for the treatment of open-angle glaucoma (OAG).
Talk about this ViaLase technology.
The ViaLase-developed ViaLuxe Laser System is designed to deliver tightly-focused, optical coherence tomography (OCT)-guided femtosecond laser pulses throughout the cornea and across the anterior chamber to the iridocorneal angle, non-invasively creating a single channel (measuring 500 μm wide by 200 μm high) through the trabecular meshwork (TM) and into Schlemm’s canal.
To simplify, the system allows a surgeon to noninvasively lower intraocular pressure (IOP) by creating channels within the TM—without damaging adjacent tissue.
Talk about this study.
The prospective, single-center, non-randomized, 12-month study assessed the safety of using FLigHT and its potential IOP-lowering effect. A total of 9 patients (15 eyes) were enrolled, all of whom were previously diagnosed with either OAG or ocular hypertension.
Each patient received a medication washout before receiving the FLigHT + laser system-incorporated procedure.
Didn’t they just release data from this study?
Yes! Those results were based on the study’s 12-month duration—not the 24-month follow-up. Read more about the data readout here.
Now talk about this follow-up.
Investigators initially enrolled 12 patients (18 eyes) with OAG who underwent FLigHT; 11 patients (17 eyes) returned at the 24-month follow-up.
At the assessment, adverse events (AEs), rate of best-corrected visual acuity (BCVA) loss, and IOP reduction were observed.
Findings?
In the 11 patients (17 eyes), investigators observed no serious AEs related to treatment; the channels appeared well-defined, clearly visible, and with no evidence of closure (seen using gonioscopy and anterior segment optical coherence tomography [AS-OCT]); and the mean IOP was reduced by 34.6%.
Further, 14 out of 17 eyes achieved a 20% or greater IOP reduction when compared to baseline.
Significance?
The favorable safety profile of FLigHT—including IOP reduction—offers the potential for a non-invasive treatment option to fulfill an unmet need for treating glaucoma.
What’s next?
ViaLase is currently enrolling patients for a multicenter, randomized trial to further support the FIH study findings. Stay tuned for further results!