FDA Supports Proposed Clinical Study of Bausch + Lomb’s BL1243 for Dry AMD

Bausch + Lomb has received FDA support, in principle, for the proposed initial clinical study of BL1243 (tonabersat), an investigational oral therapy being developed for earlier-stage dry age-related macular degeneration (AMD). The company plans to initiate the dry AMD clinical program in 2027.

Bausch + Lomb Corporation said a recent meeting with the FDA provided greater clarity on the clinical development pathway for BL1243. The agency was supportive, in principle, of the proposed design of an initial study intended to evaluate the pharmacokinetic profile and safety of the investigational therapy.

According to the company, results from this initial study could support progression into a Phase 2 study if no unexpected findings emerge. The proposed Phase 2 program would evaluate BL1243 in patients with dry AMD who have not yet developed advanced retinal damage.

Prior Clinical Experience with Tonabersat

The development of BL1243 builds on previous clinical experience with tonabersat involving approximately 2,100 people. This includes a 63-participant study conducted by the DRCR Retina Network in patients with diabetic macular edema, another retinal disease.

In that study, oral tonabersat administered at 80 mg demonstrated evidence of target engagement and pharmacological activity and was tolerated. Bausch + Lomb is now advancing tonabersat as BL1243 for investigation in dry AMD.

However, the previous clinical experience does not establish that tonabersat is effective in dry AMD. Prospective clinical studies in the target population will be required to determine the safety, efficacy and therapeutic potential of BL1243.

Yehia Hashad, M.D., chief medical officer and executive vice president of Research & Development at Bausch + Lomb, highlighted the unmet need among patients earlier in the course of dry AMD. The company is evaluating the potential of an oral approach supported by previous clinical experience with tonabersat.

Earlier-Stage Dry AMD Remains an Unmet Need

Dry AMD is the most common form of AMD and is a progressive condition affecting the macula, the retinal region responsible for central vision. Earlier-stage disease may cause few or no symptoms, while progression can lead to increasing difficulty with activities such as reading, driving and recognizing faces. Late-stage dry AMD can progress to geographic atrophy, which is associated with permanent vision loss.

Treatment options for patients who have not developed advanced retinal damage remain limited. Phil Rosenfeld, M.D., Ph.D., professor of ophthalmology at Bascom Palmer Eye Institute, noted that an oral therapy, if successfully developed, could provide a non-invasive alternative to treatments administered by injection into the eye and potentially support earlier intervention.

Planned Development Pathway

Bausch + Lomb plans to begin the BL1243 dry AMD clinical program in 2027. The initial study is intended to provide pharmacokinetic and safety information that could inform subsequent development.

If the initial study produces supportive results and no unexpected safety findings emerge, the company expects the program could progress to Phase 2 in patients with earlier-stage dry AMD. The proposed development pathway remains subject to clinical findings and regulatory requirements.

BL1243 remains an investigational therapy and has not been established as a treatment for dry AMD. The FDA’s support for the proposed study design does not represent approval of BL1243 or establish its efficacy. Further clinical evaluation will be required to determine whether the therapy can provide a meaningful benefit for patients with earlier-stage disease.

Reference

Bausch + Lomb Advances Novel Oral Treatment for Dry AMD Following Constructive FDA Meeting, Bausch + Lomb,  06 October 2026