Study: Elios combined with cataract surgery, delivers significant IOP reduction out to 8 years

Elios Vision Inc. announced this week 8-year follow up results of its novel Elios Excimer Laser Trabeculostomy procedure combined with cataract surgery.

According to the company, key findings are:

• 161 eyes of 128 patients with glaucoma or ocular hypertension and cataract received Phaco-Elios, and were followed over an 8-year period
• Significant mean IOP reduction from 19.3 mmHg at baseline to 15.4 mm Hg after 8 years of follow-up (p = 0.0040)
• Significant reduction in medication requirements
• Only 3.7% of patients required secondary surgical glaucoma intervention during the 8-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 8 years," Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an adjunct professor of Ophthalmology at the University of Minnesota, said in a news release.

“It is encouraging for patients that the number of topical medications required to control IOP was reduced significantly up to 4 years and remained below baseline levels across the entire 8-year follow-up period,” he added.

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 eyes 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 US 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 4 years, and up to 81% of patients “medication free” at 1 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 are not controlled by medications or SLT because it reduces IOP to mid-teens for at least 8 years, minimizes postop inflammation, avoids intraocular implants, 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 hypertension4.

According to the company, these findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure.

The company concluded that routinely combining cataract and glaucoma treatment is appealing since it can reduce the undesirable burden and side effects of drops and it can avoid patients undergoing two separate surgical procedures which also is more efficient for healthcare systems.

References

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. JAMA. 2012;308(5):493–501.