ViaLase, Inc. has completed enrollment for VIA-002, its pivotal trial featuring the company’s ViaLase Laser for patients with primary open-angle glaucoma (POAG).
Let’s start with this laser.
The ViaLase-developed ViaLuxe Laser System is designed to deliver tightly-focused, optical coherence tomography (OCT)-guided femtosecond laser pulses across the anterior chamber to the iridocorneal angle, non-invasively creating channels within the trabecular meshwork (TM) and into Schlemm’s canal.
Translation?
To put it simply, the system can allow a surgeon to non-invasively lower intraocular pressure (IOP) by creating channels within the TM—without potentially creating collateral damage in adjacent tissue.
And the end result: delivering a non-invasive glaucoma treatment called femtosecond laser image-guided high-precision trabeculectomy (FLigHT)
Watch this video to see how it works.
Any prior data on this laser?
Yes! The company previously reported 24-month data from its first-in-human (FIH) FLigHT study using the ViaLase laser technology as a follow-up to previously reported 12-month data (reported back in March 2023).
Both data sets pointed to a favorable safety profile of FLigHT, including IOP reduction, as a non-invasive POAG treatment.
Read the details here.
Now this pivotal trial.
VIA-002 is a prospective, randomized, controlled, multi-center study assessing the use of the ViaLase Laser compared to selective laser trabeculoplasty (SLT) in POAG patients.
A total of 152 adult participants have been randomized to receive either the ViaLaser Laser or SLT.
What’s being measured?
Primary effectiveness endpoint
- Reduction in mean unmedicated IOP
- Measured at baseline to 6 months
Secondary effectiveness endpoints
- Percentage of eyes with a >20% reduction in unmedicated IOP
- Measured at 6 months and 12 months, with no secondary surgical intervention to treat glaucoma
- Reduction in mean number of hypotensive medications
- Measured from screening to 6 months and 12 months.
When can we expect results?
Likely sometime in 2024… so stay tuned!