Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, announced progress in the development of BL1243 (tonabersat), an investigational oral treatment for dry age-related macular degeneration (AMD), following a constructive meeting with the U.S. Food and Drug Administration (FDA).

The discussion provided greater clarity on the clinical development path for BL1243. If successfully 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 Yehia Hashad, chief medical officer and executive vice president of Research & 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 Phil Rosenfeld, M.D., Ph.D., 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.