Bausch + Lomb Advances Novel Oral Treatment for Dry AMD Following Constructive FDA Meeting

The FDA supported the initial study design in principle; advancement toward Phase 2 is expected barring unexpected findings.

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• BL1243 (tonabersat) is being developed as a potential oral treatment for patients with earlier-stage dry AMD, where treatment options remain limited
• Clinical development program expected to begin in 2027

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 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.

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 mg) 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
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. Forward-looking statements including the company’s proposed development path for the BL1243 program and the timing of same, as well as the expected impact of this program. 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.

© 2026 Bausch + Lomb.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261006322876/en/

Media Contact:
Caryn Marshall
caryn.marshall@bausch.com
(908) 493-1381

Investor Contact:
George Gadkowski
george.gadkowski@bausch.com
(877) 354-3705 (toll free)

Source: Bausch + Lomb Corporation

Key Terms

age-related macular degeneration medical

Age-related macular degeneration is an eye condition in older adults where the central part of the retina (the macula) progressively loses function, blurring or erasing the sharp, central vision used for reading, driving, and recognizing faces. Investors care because it creates sustained demand for drugs, medical devices, diagnostics, and care services—think of the macula as the camera’s center; if it fails, the market for treatments and related healthcare products can be large and long-lasting.

fda regulatory

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

phase 2 medical

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.