Intraocular pressure is the fluid pressure inside the eye, similar to the air pressure in a tire or the tension in a water balloon that helps the eye keep its shape. It matters to investors because sustained high pressure can lead to glaucoma and vision loss, driving demand for drugs, surgical devices, diagnostics and related regulatory approvals and reimbursements, which directly affect company revenues and risk profiles.
open angle glaucomamedical
A common, chronic eye disease in which fluid pressure inside the eye slowly damages the optic nerve, typically causing gradual loss of peripheral vision that can progress to blindness if untreated. Investors care because its high prevalence and lifelong treatment needs create steady demand for medications, surgical devices, and diagnostic tools; new drug approvals or device breakthroughs can materially change market size, reimbursement, and company valuations.
excimer lasermedical
An excimer laser is a high-energy, pulsed ultraviolet light device that removes or reshapes tiny amounts of material with extreme precision, like a scalpel made of light. Investors watch it because it underpins key businesses—such as corrective eye surgery and semiconductor manufacturing—so demand, regulatory approval, maintenance cycles, and technological upgrades for excimer lasers can meaningfully affect revenue, margins, and competitive positioning of companies that make or use them.
ce markedregulatory
CE marked indicates that a product meets European Union safety, health and environmental requirements and bears the CE symbol, acting like a safety stamp or passport that allows the product to be sold across the EU and European Economic Area. For investors, a CE mark matters because it reduces regulatory barriers and legal risk, can speed market access and revenue, and signals the company has cleared essential compliance steps for that product—affecting sales potential, costs and valuation.
intraoperative complicationsmedical
Events or problems that occur while a surgical operation is taking place, such as unexpected bleeding, injury to surrounding tissues, equipment failure, or anesthesia issues. They matter to investors because they can increase treatment costs, delay or derail clinical trials and product approvals, lead to legal or regulatory consequences, and affect hospital and device maker reputations—think of them as unexpected breakdowns during a complex machine repair that raise expense and risk.
postoperative adverse eventmedical
A postoperative adverse event is an unintended medical complication that occurs after a surgical procedure, such as infection, bleeding, wound problems, organ issues, or the need for another operation. Investors care because how often and how severe these complications are shapes a medical product or hospital’s safety reputation, can trigger regulatory actions, recalls or lawsuits, and often leads to higher costs or slower adoption—much like repeated product failures erode customer trust and sales.
diurnal iopmedical
Diurnal IOP is the pattern of a person’s eye pressure measured at multiple times across a day, showing how intraocular pressure rises and falls in a normal daily cycle. For investors, it matters because treatments or devices that lower or stabilize this daily pressure profile can reduce disease progression and drive regulatory approval, adoption, and market value—like a thermostat keeping room pressure steady rather than letting it spike.
minimally invasive glaucoma treatmentmedical
Minimally invasive glaucoma treatment (MIGT) are medical procedures or small implanted devices that lower pressure inside the eye using tiny cuts or micro‑tools, aiming for quicker recovery and fewer complications than traditional glaucoma surgery. Investors care because MIGT can broaden patient use, shorten hospital time and reduce costs, so regulatory approvals, insurance reimbursement and device sales can materially affect revenue and growth prospects—think of it as a compact, easier-to-use alternative to a bulky surgical tool.
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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).
VAUGHAN, Ontario--(BUSINESS WIRE)--
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.
