Kala Pharmaceuticals’ (NASDAQ:KALA) KPI-121 (loteprednol etabonate) for acute symptoms of dry eye will have difficulty achieving its Phase III co-primary endpoint of significant ocular discomfort reduction as the drug demonstrated a failure in Phase II, said experts.
The trial design between Phase II and Phase III are very similar, with the only discernable difference being duration, and could see a replication in the failure. However, they added, the other co-primary endpoint of bulbar conjunctival hyperemia reduction has a good chance of repeating Phase II success.