Elios Reports 8-Year Results of its Excimer Laser Trabeculostomy Procedure Combined With Cataract Surgery

Elios Vision announced 8-year follow up results of its Elios Excimer Laser Trabeculostomy procedure combined with cataract surgery. According to Elios, key finding of the study include:

• 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 mmHg 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 postoperative 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 postoperative 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 company 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."

The Elios procedure creates ten ‘microchannels (210µm)’ in the trabecular meshwork using an excimer laser. The microchannels facilitate aqueous outflow into Schlemm’s canal, 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.

These findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure, according to Elios. 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 health care 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.