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Shawn O'Neil of ViaLase shares updates on the company's femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) treatment.
Note: This transcript has been lightly edited for clarity.
Sean O'Neil: Hi, this is Sean O'Neil, Chief Commercial Officer of ViaLase. Excited to be at the Eyecelerator meeting at AAO and provide an update on ViaLase milestones.
ViaLase is a medical device company, it's venture backed, out of Southern California. We are focused on disrupting the current conventional glaucoma treatment paradigm with the introduction of a non-invasive, image-guided femtosecond laser to address primary open angle glaucoma.
The leadership team has a vast experience in femtosecond lasers, designing, manufacturing, commercializing, the first femtosecond laser for both refractive as well as cataract and now looking to take that knowledge and leverage it within the glaucoma marketplace.
I'm excited to announce that the founder and CEO Dr. Tibor Juhasz was recently awarded the 2022 Golden Goose Award in recognition of his and his fellow researchers, finding that femtosecond lasers can make corneal incisions with high precision without damaging adjacent tissues, which revolutionized the LASIK marketplace. And we look forward to ViaLase taking that experience and recreating it and that success for glaucoma patients.
As we know with glaucoma, glaucoma treatment paradigm is typically driven by a trade-off thought process. If you want more efficacy, you typically have to give up safety. We're designing our technology to bring those into balance. And the technology is designed to create a femtosecond laser, image-guided, high-precision trabeculotomy, what we're calling the FLigHT treatment.
The FLigHT treatment again is is to include OCT-driven femtosecond laser delivery for safety and efficacy but also with an intuitive learning curve, so that is accessible to all surgeons, glaucoma specialist and cataract surgeons alike. And we're we're also working on a business model so that there is value for all stakeholders.
We're excited to provide here, at AAO Eyecelerator, a case series of data to assess safety and efficacy of an 18 patient case series non-washed-out, so real-world out to 24 months. 24 months is important in glaucoma because you want that long-term data to assess both safety as well as durability of treatment.
Of the patients in the cohort out to 24 months, they demonstrated a 31% IOP reduction and also excited to say that 100% of them achieved the 20% or greater IOP reduction, all with a very safe profile.
This data is very encouraging and we look forward to demonstrating our results in a multicenter, randomized controlled trial that is currently ongoing. Finally we are in the process of getting CE mark and we're also preparing for our submission to the FDA for 510K clearance and look forward to keeping you updated on those milestones as we prepare for commercialization.