ViaLase announced that the company has completed enrollment for VIA-002, a pivotal trial of the ViaLase Laser to treat adult patients with primary open-angle glaucoma (POAG). The ViaLase Laser combines femtosecond laser technology and micron-level image guidance to deliver a noninvasive glaucoma treatment called femtosecond laser image-guided high-precision trabeculotomy, or FLigHT. The ability to noninvasively create a conduit between Schlemm's canal and the anterior chamber is an advantage unique to the FLigHT procedure, according to the company.

The VIA-002 trial is a noninferiority efficacy study comparing the ViaLase Laser to selective laser trabeculoplasty (SLT) in adult patients with POAG. The 152 patients enrolled in this prospective, randomized, controlled, multicenter trial will be randomized to either the ViaLase Laser or SLT. The primary effectiveness endpoint is a reduction in mean unmedicated intraocular pressure (IOP) from baseline to 6 months and 12 months. Secondary effectiveness endpoints are the percentage of eyes with a >20% reduction in unmedicated IOP at 6 months and 12 months with no secondary surgical intervention to treat glaucoma, and a reduction in mean number of hypotensive medications from screening to 6 months and 12 months.

“There is a significant unmet need for a noninvasive, nonpharmacologic treatment for glaucoma patients who are not ready for cataract surgery or who have already had cataract surgery and are struggling on medical therapy,” said Tibor Juhasz, PhD, founder and chief executive officer of ViaLase, in a news release. "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.”

"We are hopeful the results of this trial will be consistent with our first-in-human study, which published data of patients followed out to 24 months,”¹ said Richard Lewis, MD, chief medical officer of ViaLase. “ViaLase believes our technology will give doctors the opportunity to intervene earlier in the treatment paradigm with a potentially safe and effective noninvasive procedure.”

Reference

1. Nagy ZZ, Kranitz K, Ahmed IIK, De Francesco T, Mikula E, Juhasz T. First-in-human safety study of femtosecond laser image-guided trabeculotomy for glaucoma treatment: 24-month outcomes. Ophthalmol Sci. 2023;3(4):100313. Published 2023 Apr 17. doi:10.1016/j.xops.2023.100313