ESCRS 2024: 36-month results following femtosecond laser image-guided high precision trabeculotomy (FLigHT)

This year, the European Society of Cataract and Refractive Surgeons holds its congress in Barcelona, Spain. We spoke with Rick Lewis, MD, about the femtosecond laser image-guided high precision trabeculotomy (FLigHT) procedure from ViaLase, the company’s recent CE mark and 36-month results he presented at the meeting.

Editor’s note: The below transcript has been lightly edited for clarity.

Hattie Hayes: Hi, and welcome to Ophthalmology Times Europe. This year, the meeting of the European Society of Cataract and Refractive Surgeons is in Barcelona. Joining me today, I have Dr Rick Lewis, who is the Chief Medical Officer at ViaLase, who's going to talk about what he's bringing to the meeting. Dr Lewis, thank you so much for being here.

Rick Lewis, MD: Thank you for the kind introduction. You know, it's a pleasure to be here and share what I think is very exciting data from our initial phase one safety study at ViaLase. We evaluated channel patency, intraocular pressure and safety over a 36-month period in our initial cohort of open angle glaucoma patients, looking at the FLigHT treatment; FLigHT stands for [femtosecond laser] image-guided high precision trabeculotomy. This was a prospective, single-centre study. It wasn't randomised. It was 18 eyes with 12 patients and started back in 2020. We had our prototype machine and were able to create, without any safety issues, a channel in the trabecular meshwork of 200 by 500 microns, and this is a non-incisional trabeculotomy. What separates the approach with ViaLase is that the patient interface, like what you get with IntraLase or LenSx, is applied to the patient's eye after applying topical anesthetic. The procedure takes minutes. There's no incision, there's no restrictions post-op, there's no hyphema, and the patient has a trabeculotomy.

We were able, in the study, to follow them over the course of 3 years. Our data is impressive. We got pressure reductions of almost 7 millimeters. A few patients did need to require medications, but the vast majority did not, and our safety, both initially and at 3 years, was remarkably good. So we're very excited about this.

We're actually in the middle of other studies now, some of our pivotal studies, and we're happy to report that we have applied for and received EU approval, European Union approval, to launch this product in Europe, [either at the] end of this year, or more likely, the first quarter of next year. This will be, again, the FLigHT treatment with ViaLase. So it's an exciting time. We have a number of presentations at this year's ESCRS meeting, including the iNovation session.

This particular abstract will be presented in the scientific programme. We have a series of other meetings, and are very excited to launch this new approach to treating glaucoma.

HH: I was lucky enough to report on that CE Mark that the ViaLase laser received in the EU just just a few weeks ago. What do you think that that approval, and this procedure, says about the changing landscape of both glaucoma care and refractive care?

RL: I've been in glaucoma for close to 40 years, and it's always been frustrating. You know, historically, we have treated glaucoma with topical eye drops, which we all know patients are non-compliant and create a significant ocular surface problem for those patients, not only in glaucoma, but for refractive and cataract surgery. The ability to create a trabeculotomy without a corneal incision will add a unique and special opportunity in treating these patients, both early and late in the disease. And I think that represents, truly, like you say, a paradigm shift in the management of this disease. I'm excited by it. And when you look at the technology, most everyone gets excited by it. This is very unique, and it isn't even the creation of the trabeculotomy. It's our imaging system, both gonioscopic imaging and OCT imaging, that allows very precise placement. With a commercialised device, we will be able to place one, two, three or even four channels. And there is very little risk involved in this, and it avoids all the problems that happen with intraocular trabeculotomy. So a very exciting opportunity. And again, between this and some of the other laser treatments, I think the paradigm of using medications early will probably be changed.

HH: The other major aspect of the FLigHT procedure that makes it so unique is that it's something that extends treatment to patients regardless of their lens status. What do you think is so important about accessibility, especially for patients in Europe?

RL: Well, you know, the issue with lens status has to do, of course, with all the approved MIGS treatments. In any area, whether it's Europe or North America, the approval process demanded that a cataract surgery be done in conjunction with most of the device-related MIGS procedures. Well, not everybody, of course, has cataracts, or perhaps has had cataract surgery in the past, and cannot be a combined procedure. The opportunity here to do it in phakic eyes and pseudophakic eyes, in primary glaucoma and secondary glaucoma, in a variety of age groups, whether it's...an ideal treatment in the future for early juvenile-onset glaucoma, and certainly even in the elderly. Because the risk factor is significantly reduced. Now, we don't have data yet on some of these secondary glaucomas, but the opportunity is obvious and will certainly be pursued.

HH: I know that you and I have discussed how we're both turning our European conference travel into vacations this year, because we're smart! But the ESCRS is such a big congress. Tell me a little bit about what you're looking forward to discussing or debating with your colleagues there.

RL: You know, ophthalmology is such an exciting field, and there's so many things going on at all these different levels. You know, whether it's cornea, refractive or cataract, the new lenses, the laser-adjusted lenses, the ability to treat glaucoma with non-pharmaceutical ways, you know, the cornea treatment, there's exciting areas of replacing cornea. You learn so much at these meetings, and just getting to see your colleagues and hear the latest presentations, I feel very fortunate that I'm in ophthalmology. I can't think of a more exciting field than this.

HH: Well, I feel very fortunate that you've joined me this morning to discuss the meeting, and I'm sure that our viewers will feel the same. Thank you so much for your time and safe travels!