BVI Medical Secures FDA Clearance For Leos™, A Breakthrough In Minimally Invasive Glaucoma Surgery

BVI Medical, a global leader in ophthalmic devices, has received 510(k) clearance from the U.S. FDA for its groundbreaking glaucoma treatment device, Leos™ (Laser Endoscopy Ophthalmic System). This approval makes way for a new era in glaucoma surgery, with Leos offering a more streamlined and involuntary Laser Endoscopic Cyclophotocoagulation (ECP) procedure. 

“This momentous milestone underscores our commitment to innovation. We have been building a strong pipeline starting to play out in numerous geographies worldwide, including Leos in the US market, ” said Shervin Korangy, BVI President and CEO. 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.

Leos™ is the first laser system to lower intraocular pressure through a minimally invasive ab interno method, directly targeting the eye’s aqueous humour production. It stands out due to its integrated endoscopic technology, which provides unmatched visualisation of internal eye structures and surpasses traditional and current imaging systems. This advanced functionality supports safer and more effective surgical outcomes.

Mikhail Boukhny, Vice President, Global R&D, 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 practical 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.” 

This FDA clearance represents a critical milestone in expanding glaucoma treatment options, particularly for patients in earlier stages and across diverse glaucoma types. With over 76 million people affected globally, projections are rising to 111.8 million by 2040, and Leos has the potential to address a significant unmet need. Supported by positive data from a randomised controlled clinical trial, BVI Medical plans to launch Leos in the U.S. shortly.