Limited Durability Of Imaging EvidenceCorneal image findings come from a small exploratory analysis and lack definitive power, so nerve-structure improvements require confirmation in larger trials before being considered reliable.
Regulatory Evidence RiskDependence on exploratory imaging endpoints could complicate regulatory review if confirmatory studies do not show consistent clinical benefit tied to those structural measures.
Replication RiskReliance on exploratory imaging signals increases the risk that larger, controlled trials may not reproduce the structural improvements observed in Phase 2, which would weaken the overall efficacy case.