Dr. Yehia Hashad reports

BAUSCH + LOMB ADVANCES NOVEL ORAL TREATMENT FOR DRY AMD FOLLOWING CONSTRUCTIVE FDA MEETING

Bausch + Lomb Corp. has made progress in the development of BL1243 (tonabersat), an investigational oral treatment for dry age-related macular degeneration, following a constructive meeting with the U.S. Food and Drug Administration.

The discussion provided greater clarity on the clinical development path for BL1243. If developed and approved, BL1243 could offer a differentiated oral treatment option for patients with dry AMD. The program is part of Bausch + Lomb's robust pipeline and underscores the company's commitment to advancing the standard of care in eye health.

"Dry AMD represents a significant unmet need, particularly for patients earlier in the course of disease, and we believe there is a real opportunity to change how and when these patients are treated," said Dr. Yehia Hashad, chief medical officer and executive vice-president of research and development, Bausch + Lomb. "The oral route of administration, prior clinical experience and potential application in earlier-stage disease make BL1243 a particularly compelling program as we continue building the next generation of treatments for eye health."

"For people with dry AMD, a safe and effective oral treatment could offer an important new option," said Dr. Phil Rosenfeld, MD, PhD, professor of ophthalmology, Bascom Palmer Eye Institute. "Treatment choices are limited for patients who have not yet developed irreversible vision loss. An oral therapy could provide a convenient, non-invasive alternative to treatments administered by injection into the eye. If successful, it could also give physicians an opportunity to intervene earlier in the course of disease."

Clearer path to clinical development:

• The FDA was supportive, in principle, of the proposed initial study design, which will evaluate how the medicine behaves in the body and assess its safety.
• Barring unexpected findings, results from the initial study are expected to support advancement into a phase 2 study in patients with dry AMD who have not yet developed advanced retinal damage.
• The discussion addressed the need for treatment approaches that could enable intervention earlier in the course of dry AMD.

Bausch + Lomb plans to initiate its dry AMD clinical program in 2027, marking the next step in the development of BL1243.

About BL1243 (tonabersat)

BL1243 is an investigational oral medicine being developed to address biological processes believed to contribute to retinal damage in dry AMD. The program builds on prior clinical experience with tonabersat in approximately 2,100 people, including a 63-participant study conducted by the DRCR retina network in diabetic macular edema, another retinal disease.

In that study, oral tonabersat (80 milligrams) demonstrated evidence of target engagement and pharmacological activity, and was tolerated (Barkmeier et al., Ophthalmology Science, March, 2026). Bausch + Lomb is now advancing tonabersat as BL1243 for the treatment of dry AMD.

About dry AMD

Dry AMD is the most common form of age-related macular degeneration, a progressive eye disease caused by damage to the macula, the part of the retina responsible for sharp central vision. As the disease advances, it can make everyday activities such as reading, driving and recognizing faces increasingly difficult, and may progress to geographic atrophy, an advanced form associated with permanent vision loss.

About Bausch + Lomb Corp.

Its mission is simple -- it helps people see better to live better, all over the world. For nearly two centuries, it has 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, it is turning bold ideas into better outcomes through passion, perseverance and purpose.

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