Dr. Yehia Hashad reports

BAUSCH + LOMB ANNOUNCES POSITIVE 24-MONTH U.S. DATA ON THE ELIOS(TM) SYSTEM FOR TREATMENT OF GLAUCOMA

Bausch + Lomb Corp. has released positive 24-month results from the pivotal United States 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 Food and Drug Administration 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, research and development, 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 data set with the broader ophthalmic community."

In the prospective, multicentre 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 end points were evaluated: the percentage of patients achieving at least a 20-per-cent reduction in IOP and mean IOP reduction.

The Elios system met the study's co-primary effectiveness end points, demonstrating both statistically significant and clinically meaningful IOP reduction. Key results included:

• Unmedicated diurnal IOP (DIOP) was reduced by 20 per cent or greater in 76 per cent of patients;
• Patients experienced an average of 7.4 mmHg decrease in unmedicated DIOP;
• 82 per cent 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 top-line results will be discussed at 1:30 p.m. ET today during the inaugural Bausch + Lomb R&D teach-in webinar. 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 United States' Food and Drug Administration (FDA) for safety or effectiveness.

Elios has been available in Europe for several years, and data on the Elios procedure have been published in 12 clinical studies1 with more than 850 eyes treated showing an IOP reduction of 20 to 40 per cent from baseline, a significant reduction of medication for up to four years, up to 81 per cent of patients medication free at one year and a favourable 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 Corp.

The company's mission is simple -- it helps people see better to live better, all over the world. For nearly two centuries the company evolved with the changing needs of patients and customers, and its 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, the company was turning bold ideas into better outcomes through passion, perseverance and purpose.

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