Bausch + Lomb (BLCO) said Tuesday it advanced clinical development of its investigational oral treatment for dry age-related macular degeneration after a constructive meeting with the US Food and Drug Administration.
The regulatory agency was supportive, in principle, of the proposed initial study design to evaluate how the medicine behaves in the body and assess its safety, the company said.
The eye health firm expects these initial results to support advancement into a phase 2 study for patients with dry AMD who have not yet developed advanced retinal damage and plans to start the clinical program in 2027, Bausch + Lomb said.
The BL1243 program aims to address biological processes believed to contribute to retinal damage and leverages previous clinical experience involving roughly 2,100 people, the company added.