ViaLase Inc. announced that the first patient has been treated in an investigational device exemption (IDE) clinical trial evaluating the company’s noninvasive laser treatment for glaucoma.
The Aliso Viejo-based clinical-stage medtech startup’s main product is the ViaLase Laser System, which emits short pulses of light to create microscopic channels in the eye to help drain excess fluid and reduce pressure.
“This IDE trial is an important step toward making the ViaLase procedure broadly available to the millions of glaucoma patients in need,” ViaLase Chief Executive Shawn O’Neil said in a statement.
The company has already received CE Mark approval in the European Union last year and is working toward approval and commercialization in the U.S., which is dependent upon the ongoing IDE trial.
If approved, the treatment would be the first femtosecond laser used for primary open-angle glaucoma.
Glaucoma affects 76 million people worldwide, with the figure expected to increase to 112 million by 2040, and is the second leading cause of irreversible blindness in the world, according to ViaLase.
The company, founded in 2019, has the backing of well-known local investor Bill Link and has raised more than $75 million to date, including a $40 million Series C round last April.
Randomized, Controlled Trial
The randomized, controlled trial is comparing ViaLase’s procedure to selective laser trabeculoplasty (SLT), the current standard of treatment for reducing intraocular pressure.
It’s being led by Dr. Thomas Samuelson, the founding partner and attending surgeon at Minnesota Eye Consultants, who said it’s the first trial of its kind.
“For the first time, we will have randomized data comparing a next-generation incision-free canal procedure against SLT,” Samuelson said in a statement.
SLT uses low levels of laser light to improve fluid drainage from the eye, typically lasting between two and three years.
ViaLase, on the other hand, has developed a noninvasive, image-guided femtosecond laser treatment that creates a new drainage channel without any incisions. A femtosecond laser emits short pulses of light, with each pulse lasting for just one quadrillionth of a second.
The current treatment model for glaucoma usually begins with topical eye drops, then may advance to laser therapy or minimally invasive glaucoma surgery (MIGS), before resorting to filtration surgery, according to ViaLase.
CEO Transition
ViaLase in July announced that O’Neil was succeeding founder and former CEO Dr. Tibor Juhasz, who stepped down to president and chief technology officer.
The transition came as the company prepares for regulatory approvals and commercial launch in the U.S. and Europe, with O’Neil said to have a strong track record of “bringing new technologies into mainstream clinical use,” according to ViaLase.
Juhasz, a laser physicist, is credited with scientific breakthroughs that led to the development of LASIK.
He, along with RxSight Inc. CEO Ron Kurtz and three other researchers, discovered the femtosecond laser’s capacity to create ocular tissue incisions with micron-level precision without damaging adjacent tissue.
This discovery eventually led Juhasz and Kurtz in 1997 to create what would become Irvine’s IntraLase Corp., which Advanced Medical Optics acquired for $808 million in 2007.
“Tibor has one of the great minds in this area. He has a very successful track record,” Jim Mazzo, a top business executive in OC’s ophthalmology industry, previously told the Business Journal.
