US-based ophthalmologic devices maker BVI Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its laser endoscopy ophthalmic system, Leos.
The advanced laser-based system is expected to advance glaucoma care, particularly in the early stages and across various types of the disease.
Leos features a unique mechanism of action designed to deliver vibrant, high-quality visualisation of eye anatomy, offering a significant advancement in ophthalmic technology.
The system introduces a novel Laser Endoscopic Cyclophotocoagulation (ECP) procedure, which integrates smoothly into the surgical workflow.
It is the only laser system that reduces intraocular pressure by addressing aqueous humour production through a minimally invasive procedure, said the medical device company.
BVI president and CEO Shervin Korangy said: “This momentous milestone underscores our commitment to innovation. We have been building a strong pipeline that is starting to play out in numerous geographies across the world, including Leos in the US market.
“The momentum for BVI continues to build behind a recent $1bn capital raise and several very high-profile product approvals in the EU and Asian markets.”
The FDA approval of Leos represents a key development in glaucoma treatment.
The system’s efficacy and safety are supported by data from a randomised controlled clinical trial, further validating its potential in glaucoma care.
BVI Medical plans to launch Leos commercially in the US in the coming months, aiming to provide ophthalmologists with an advanced tool for managing glaucoma effectively.
BVI global R&D vice president Mikhail Boukhny said: “The development of Leos was driven by a deep understanding of the challenges clinicians face in managing glaucoma, such as visualisation and access to target tissue.
“Our goal was to create a system that not only offers a novel and effective treatment approach but also enhances the surgical experience through improved intuitiveness, precision, and ease of use.
“This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their patients.”
