According to the company, its ViaLase Laser combines the precision of femtosecond laser technology and the accuracy of micron-level image guidance to deliver the world's first femtosecond laser image-guided high-precision trabeculotomy.
ViaLase Inc. today announced it has completed enrollment of VIA-002, the company's pivotal trial of the ViaLase Laser to treat adult patients with primary open angle glaucoma (POAG).
According to a news release,1 the ViaLase Laser combines the precision of femtosecond laser technology and the accuracy of micron-level image guidance to deliver a noninvasive glaucoma treatment called femtosecond laser image-guided high-precision trabeculotomy, or FLigHT.
Tibor Juhasz, PhD, founder and CEO of ViaLase, noted in the news release that the company is pleased to have its pivotal trial fully enrolled with a total of 152 patients.
"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,” Juhasz said in the 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."Richard Lewis, MD, chief medical officer, ViaLase, noted the highlights of the study in the news release .
"VIA-002 is a non-inferiority efficacy study comparing the ViaLase Laser to selective laser trabeculoplasty (SLT)," Lewis said in the news release. "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.”
Moreover, Lewis noted the company believes its technology will give doctors the opportunity to intervene earlier in the treatment paradigm with a potentially safe and effective noninvasive procedure.
According to the company, VIA-002 is a prospective, randomly assigned, controlled, multi-center trial of the use of the ViaLase Laser versus SLT in adult patients with POAG. In the study, 152 subjects were randomized to either the ViaLase Laser or SLT.1
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.1
About the ViaLase Laser
The company noted in its release the ViaLase Laser combines a femtosecond laser and micron-level, high-definition 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.1
This technology addresses an unmet need for a noninvasive procedure for patients who would benefit from a non-pharmacological, non-surgical procedure but whose therapeutic goals do not justify the risks of a surgically invasive procedure such as minimally invasive glaucoma surgery (MIGS) or traditional filtration surgery, the company concluded in its news release.