Antonio Arce's questions to Clearside Biomedical Inc (CLSD) leadership • Q3 2024
Question
Speaking for Yi Chen, Antonio Arce asked about potential FDA concerns with redosing a TKI within six months, the estimated cost of the Phase III wet AMD program, the scientific rationale for treating geographic atrophy as a choroidal disease, and the timeline for an IND submission for the GA program.
Answer
Chief Medical Officer Dr. Victor Chong stated the company has no concerns about the FDA's view on redosing, citing positive safety data from multiple doses in the Phase II study. CEO George Lasezkay said it is premature to discuss Phase III costs. Dr. Chong explained that GA is considered a choroidal disease because choroidal damage precedes RPE cell death, and it is too early to provide a specific IND timeline, though they are advancing toward a lead candidate.