ELIOS combined with cataract surgery delivers significant IOP reduction out to 8 years

Today, Elios Vision, Inc. announced the eight-year follow-up results of its novel ELIOS^™ Excimer Laser Trabeculostomy procedure combined with cataract surgery.

Key study findings

• 161 eyes of 128 patients with glaucoma or ocular hypertension and cataract received ELIOS with phacoemulsification and were followed over an eight-year period
• Significant mean IOP reduction from 19.3 mmHg at baseline to 15.4 mmHg after eight years of follow-up (p=0.0040)
• Significant reduction in medication requirements
• Only 3.7% of patients required secondary surgical glaucoma intervention during the eight-year follow-up period
• No serious intra- or post-operative events were observed

“This large cohort study provides encouraging evidence that the “implant-free” phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or post-operative complications, and low rate of incisional secondary surgical intervention over a period of at least eight years,” said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an adjunct professor of ophthalmology at the University of Minnesota. Dr. Samuelson added that, “It is encouraging for patients that the number of topical medications required to control IOP was reduced significantly up to four years and remained below baseline levels across the entire eight-year follow-up period.”

About the ELIOS procedure

• The ELIOS procedure creates 10 “microchannels” (210µm) in the trabecular meshwork using an excimer laser.
• The microchannels facilitate aqueous outflow into Schlemm’s canal, the eye’s natural outflow pathway, reducing IOP² and preserving the integrity, structure, and function of the trabecular meshwork.
• Combining ELIOS with phacoemulsification is an implant-free, minimally invasive glaucoma procedure with a rapid learning curve for ophthalmic surgeons.
• The ELIOS procedure is approved in Europe for use in adults with glaucoma, with or without cataract, and is undergoing clinical trials in the U.S. under an investigational device exemption (IDE).
• Data on the ELIOS procedure has been published in 12 clinical studies² with over 850 eyes treated showing an IOP reduction of 20-40% from baseline, a significant reduction of medication for up to four years, up to 81% of patients “medication free” at one year,³ and a favorable safety profile.

Over the past decade minimally invasive glaucoma surgeries (MIGS) have transformed the treatment of mild to moderate glaucoma and are an attractive alternative to more invasive incisional procedures such as trabeculectomy and tube shunts. Despite the growing popularity of MIGS, combining cataract and glaucoma surgery is not yet the preferred choice by most surgeons.

This clinical study shows that the ELIOS procedure is attractive to all ophthalmic surgeons for patients with glaucoma that is not controlled by medications or SLT because it reduces IOP to mid-teens for at least eight years, minimizes post-op inflammation, avoids intraocular implants, and has a favorable safety profile, with or without cataract surgery.

Why are these findings relevant?

• In 2022, it is estimated that around 29 million people globally will undergo cataract removal and around 20% also have glaucoma or ocular hypertension.⁴
• These findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure.
• Routinely combining cataract and glaucoma treatment is appealing since it can reduce the undesirable burden and side effects of drops and patients can avoid undergoing two separate procedures, which is also more efficient for healthcare systems.

About Elios Vision, Inc.

Elios Vision, Inc. is privately held company, working to preserve sight by developing a safe and effective breakthrough solution for the millions of patients who have glaucoma. The ELIOS technology has a CE mark and has been used for a decade in Europe with thousands of patients treated. In the United States, the technology is investigational and undergoing an IDE pivotal trial.

Media & Investor contact
Ali Taghavi
ali@eliosvision.com

1. Riesen M, Funk J, Töteberg-Harms M. Long-term treatment success and safety of combined phacoemulsification plus excimer laser trabeculostomy: an 8-year follow-up study. Graefes Arch Clin Exp Ophthalmol. Published online January 16, 2022. doi:10.1007/s00417-021-05510-8.
2. Durr GM, Töteberg-Harms M, Lewis R, Fea A, Marolo P, Ahmed IIK. Current review of Excimer laser Trabeculostomy. Eye Vis (Lond). 2020 May 5;7:24. doi: 10.1186/s40662-020-00190-7. PMID: 32391398; PMCID: PMC7199329.
3. Moreno Valladares A, Puerto Amorós N, Mendez Llatas M, Pazos López M, Ahmed IIK. Combined excimer laser trabeculostomy and phacoemulsification: one year follow-up real world data of a laser-based MIGS. Arch Soc Esp Oftalmol (Engl Ed). 2021 Mar 11:S0365-6691(21)00053-8.
4. Tseng VL, Yu F, Lum F, Coleman AL. Cataract Surgery in Medicare Beneficiaries. 2012;308(5):493–501.