Bausch + Lomb Announces Positive 24-Month U.S. Data on the ELIOS™ System for Treatment of Glaucoma
- Both primary effectiveness endpoints were met, demonstrating statistically significant and clinically meaningful intraocular pressure reduction.
- ELIOS is an implant-free procedure that uses excimer laser technology for the treatment of glaucoma.
- Topline results will be discussed at 1:30 p.m. ET today on the inaugural Bausch + Lomb R&D Teach-in Webinar (register here).
Bausch + Lomb Corporation (NYSE/TSX:BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced positive 24-month results from the pivotal U.S. clinical trial of the ELIOS System. Developed for the treatment of elevated intraocular pressure (IOP) in patients with open angle glaucoma, ELIOS is an implant-free procedure that uses next generation excimer laser technology. The ELIOS procedure is currently CE marked in Europe and is under development and has not been reviewed by the FDA for safety and efficacy in the United States.
"These strong U.S. study results reinforce everything we've learned about ELIOS during the years it has been available in Europe," said Yehia Hashad, MD, executive vice president, R&D and chief medical officer, Bausch + Lomb. "Achieving meaningful reductions in intraocular pressure and freedom from medication for a majority of patients speaks to the promise of this technology. We look forward to sharing the full dataset with the broader ophthalmic community."
In the prospective, multicenter study, investigators at 20 sites across the U.S. enrolled 318 patients taking glaucoma medications. Patients were previously diagnosed with mild to moderate primary open-angle glaucoma as well as cataracts. Two co-primary effectiveness endpoints were evaluated: the percentage of patients achieving at least a 20% reduction in IOP, and mean IOP reduction.
The ELIOS system met the study's co-primary effectiveness endpoints, demonstrating both statistically significant and clinically meaningful IOP reduction. Key results included:
- Unmedicated diurnal IOP (DIOP) was reduced by 20% or greater in 76% of patients
- Patients experienced an average of 7.4 mmHg decrease in unmedicated DIOP
- 82% of patients were medication-free at 23 months
- No intraoperative complications seen during the ELIOS procedure
- Similar postoperative adverse event rate as cataract surgery alone
"The ELIOS procedure shows exciting potential for minimally invasive glaucoma treatment in the U.S., leveraging precision excimer laser technology to enhance the eye's natural outflow pathways," said Mark J Gallardo, MD, Glaucoma Fellowship Director at El Paso Eye Surgeons. "I believe glaucoma and cataract specialists alike will be very interested in the consistency of these impressive results as well as the demonstrated strong safety profile."
These topline results will be discussed at 1:30 p.m. ET today during the inaugural Bausch + Lomb R&D Teach-in Webinar (register here). Detailed results from the pivotal trial will be submitted to a future medical meeting and a peer-reviewed journal.
About the ELIOS System and ELIOS Procedure
The ELIOS procedure is an implant-free, minimally invasive glaucoma procedure that uses excimer laser technology to create microchannels in the trabecular meshwork, facilitating aqueous outflow and reducing intraocular pressure.
ELIOS is currently under development in the United States and has not been reviewed by the U.S. Food and Drug Administration (FDA) for safety or effectiveness.
ELIOS has been available in Europe for several years, and data on the ELIOS procedure has been published in 12 clinical studies1 with more than 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,2 and a favorable safety profile.
Over the past decade MIGS surgeries have transformed the treatment of mild to moderate glaucoma in Europe and have the potential to be an attractive alternative to more invasive incisional procedures such as trabeculectomy and tube shunts in the United States.
About Bausch + Lomb
Our mission is simple – we help people see better to live better, all over the world. For nearly two centuries we've evolved with the changing needs of patients and customers, and our commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, we're turning bold ideas into better outcomes through passion, perseverance and purpose. Learn more at www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.
Forward-Looking Statements
This news release may contain forward-looking information and statements within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements may generally be identified by the use of the words "anticipates," "seeks," "expects," "plans," "should," "could," "would," "may," "will," "believes," "potential," "pending" or "proposed" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
References
- Durr GM, Töteberg-Harms M, Lewis R, Fea A, Marolo P, Ahmed II. Eye Vis (Lond). 2020 May 5;7:24. doi: 10.1186/s40662-020-00190-7. PMID: 32391398; PMCID: PMC7199329.
- Moreno Valladares A, Puerto Amorós N, Mendez Llatas M, Pazos López M, Ahmed IIK. Arch Soc Esp Oftalmol (Engl Ed). 2021 Mar 11:S0365-6691(21)00053-8.
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