Kala’s KPI-121 draws reservations around its Phase III trial design and potential to rectify Phase II failure on ocular discomfort endpoint - experts
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.
KPI-121’s FDA approval will ultimately hinge on the pivotal Phase III trial delivering significant ocular discomfort relief scores, on top of strong safety signals, experts said, noting the success of the hyperemia co-primary endpoint did not seem as important. The two co-primary endpoints seemed inadequate compared to other loteprednol trials for dry eye, which usually measure objective ocular staining scores and discomfort relief scores, some experts added.