Bausch + Lomb Discussed Dry AMD Drug With FDA
The company has received support for the clinical study design of its oral treatment candidate, BL1243.
Updated on Oct. 6, 2026 in Diabetes
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Bausch + Lomb has met with the FDA to discuss the clinical development pathway for BL1243, an oral treatment currently being developed for dry age-related macular degeneration. The regulatory agency expressed support in principle for the company's proposed initial study design.
Why it matters
The program aims to address the clinical need for new therapeutic approaches that allow for earlier intervention in patients with dry AMD. By evaluating how the medicine behaves in the body and assessing safety, the company intends to build on extensive prior clinical experience with tonabersat.
Previous clinical studies of the compound tonabersat involved approximately 2,100 people, including a specific cohort of 63 participants with diabetic macular edema who received an 80 mg oral dose.
The players
Bausch + Lomb
An international eye health company based in Vaughan, Ontario, that develops pharmaceuticals and medical devices.
FDA
The United States government agency responsible for regulating the safety and efficacy of medical drugs and clinical trial designs.
The details
The proposed study will focus on characterizing the medicine's behavior within the body and establishing a safety profile. This development follows a March 2026 study published in Ophthalmology Science that utilized earlier data to support the drug's potential application.
Timeline
March 2026: Study on tonabersat published in Ophthalmology Science.
October 6, 2026: Bausch + Lomb announced FDA meeting progress.
2027: Bausch + Lomb plans to initiate its clinical program.
The Big Picture
This development follows the precedent of the clinical evaluation of tonabersat, extending its therapeutic investigation into new ophthalmological conditions.
The potential development of an oral medication could provide patients with dry AMD a different treatment route than traditional injectable therapies. This project remains in the early clinical planning stages, meaning it is not yet available for general patient use.
The takeaway
The progression of BL1243 highlights the ongoing efforts to repurpose existing compounds for new ocular indications through rigorous regulatory vetting. Future updates will focus on the company's ability to replicate safety metrics from earlier studies in this new trial environment.
What happens next
Bausch + Lomb plans to officially begin its clinical program for dry AMD in 2027, with results from the initial study expected to guide the transition into a Phase 2 trial.
Further reading
Learn more about the latest research in this field at the Diabetes section.
Source note: This article includes information reported by Financial Post.
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