ViaLase clinical trial treats US patient with laser-based glaucoma therapy

ViaLase, the California developer of laser-based glaucoma treatment, has announced that the first patient has been treated in its US Investigational Device Exemption (IDE) clinical trial.

The trial is evaluating ViaLase's femtosecond laser trabeculotomy procedure as a treatment for glaucoma, as part of the company's move towards market for its platform.

At present the ViaLase system is not for sale in the US pending regulatory clearance. In August 2024 the company announced that its ViaLase Laser device had received CE mark approval for glaucoma treatment in select European markets.

IDE trials are often understaken to support a future premarket approval submission of a device for FDA clearance. ViaLase describes its IDE trial as representing "one of the most rigorous evaluations of an incision-free approach to reduce intraocular pressure (IOP)."

ViaLase founder and CTO Tibor Juhasz has a track record in the field, having previously been behind IntraLase and LenSx - two ophthalmology developers subsequently acquired by large players in the medical device sector.

The company is positioning its glaucoma procedure as an alternative to selective laser trabeculoplasty (SLT), the current standard laser treatment for reducing IOP. ViaLase has named the procedure FLIGHT, for femtosecond laser image-guided high-precision trabeculotomy.

"Treating the first patient in this trial is a significant milestone, not only for ViaLase, but for the broader glaucoma community," said Thomas W. Samuelson, MD, medical monitor of the ViaLase IDE trial. "For the first time, we will have randomized data comparing a next-generation incision-free canal procedure against SLT."

Avoiding incisions for a safer procedure

Existing femtosecond laser-based glaucoma treatments vary in the details of their optical components and the specific areas of the eye upon which they act, but they aim to increase fluid flow and so decrease IOP. FLIGHT uses a femtosecond laser guided by optical coherence tomography to create a 500 x 200 micron drainage channel through the eye's Schlemm's Canal, and does so without making incisions in the eye.

Avoiding such incisions is considered a significant safety advantage over other intraocular glaucoma surgeries, reducing the risk of infection to essentially zero.

"The FLIGHT procedure leverages advanced imaging to ensure accurate treatment placement and enables the surgeon to overcome traditional visualization challenges," commented ViaLase in its product information.

"SLT is a widely used first-line laser therapy for glaucoma but relies on a Q-switched Nd:YAG laser, which induces cellular turnover rather than directly bypassing outflow resistance. The FLIGHT procedure, in contrast, creates a physical conduit for aqueous outflow, potentially leading to more durable IOP control."

The results of the current clinical trial should assist the translation of FLIGHT to market as an incision-free, non-pharmacologic pressure-lowering therapy, according to ViaLase.

"This IDE trial is an important step toward making the ViaLase procedure broadly available to the millions of glaucoma patients in need," said Shawn O'Neil, ViaLase CEO. "We believe our technology has the potential to begin an entirely new era in glaucoma care, one where precision, safety, and the patient experience define the standard of treatment."