The ViaLase Laser is intended to provide a noninvasive glaucoma treatment called femtosecond laser image-guided high-precision trabeculotomy, or FLigHT
ViaLase, a medical technology firm focused on the traditional glaucoma treatment paradigm, has completed enrolment for the VIA-002 trial of the ViaLase Laser for the treatment of adult patients with primary open angle glaucoma (POAG).
The ViaLase Laser is intended to provide a noninvasive glaucoma treatment called femtosecond laser image-guided high-precision trabeculotomy (FLigHT). The device blends the accuracy of micron-level image guidance with the precision of femtosecond laser technology, said ViaLase.
The prospective, randomised, controlled, multi-centre VIA-002 trial is designed to assess the use of ViaLase Laser against selective laser trabeculoplasty (SLT) in adult patients with POAG.
In the trial, 152 participants were randomised to either SLT or the ViaLase Laser.
The primary effectiveness endpoint of the trial has been defined as the decrease in mean unmedicated intraocular pressure (IOP) between baseline and six and twelve months.
The percentage of eyes with a >20% reduction in unmedicated IOP at six months and 12 months without the need for a follow-up surgical procedure to treat glaucoma, as well as a decrease in the average number of hypotensive drugs from screening to six months and 12 months, are the secondary effectiveness endpoints.
ViaLase founder and CEO Tibor Juhasz said: “There is a significant unmet need for a noninvasive, nonpharmacological treatment for glaucoma patients who are not ready for cataract surgery or who have already had cataract surgery and are struggling on medical therapy.
“We are optimistic that our pivotal trial will demonstrate the safety and efficacy of the first-ever FLigHT treatment performed by the ViaLase Laser.
“Ultimately, it is our greatest wish to be able to provide an effective noninvasive treatment to the millions of people living with glaucoma, one of the leading causes of irreversible blindness worldwide.”
In March this year, the medical technology firm announced that the FLigHT treatment carried out with the ViaLase technology was safe and effective in a first-in-human study.