ASCRS Live: 2 year results from the first in-human study of Femtosecond Laser Image Guided High-Precision Trabeculotomy (FLigHT).

Ophthalmology Times© spoke with Richard Lewis, MD, the CMO of ViaLase at the 2023 ASCRS meeting in San Diego. There he gave out team the details of his presentation for the 2 year follow up of the first in-human study of Femtosecond Laser Image Guided High-Precision Trabeculotomy (FLigHT).

Video transcript

Editor’s note: Transcript lightly edited for clarity.

Richard Lewis, MD:

Hello, I am Rick Lewis. I am an ophthalmologist based in Northern California and chief medical officer for a company called ViaLase. ViaLase is a company with a femtolaser technology that has created a procedure to perform a trabeculotomy without a corneal incision. This is using a modified patient interface lens over the eye that has a coaxial femtolaser gonioscopic imaging and really it's the imaging that provides such a unique treatment with a precise placement of the trabeculotomy. We conducted an initial 001 study to look at the safety of this and we performed the procedure in 12 patients (17 eyes) looking at the safety as well as the efficacy of femtolaser trabeculotomy. This was conducted by Dr. Zoltan Nagy in Budapest, Hungary.

Over the course of 2 years, we analyzed those patients and found that the patients did quite well. There were minimal side effects. There was no hyphema and no corneal complications. There was some slight reflux blood noted in the canal but nothing in the anterior chamber. In terms of efficacy, we followed the patients for over 2 years and had excellent results. We not only had good IOP lowering, but we also confirmed with imaging that these trabeculotomy remained patent throughout the course of those 2 years. Our data showed approximately 38% to 40% reduction in IOP over that period of time. Using that data we are going on to a pivotal US trial that we're conducting now and this is about 80% enrolled. We expect to have full enrollment by summer of 2023. So in summary, this is a unique nonincisional approach to glaucoma creating a trabeculotomy. It is safe and effective to date. Thank you.